Dietary interventions such as very-low-calorie diets and low-carbohydrate diets can improve glycemic control and even induce type 2 diabetes (T2D) remission. However, less is known about the effects of carbohydrate-rich whole foods, such as whole fruit, in people with T2D. Therefore, the aim of this pilot study is to investigate the effects of a whole fruit-rich diet on glycemic control, ectopic fat, and cardiovascular risk factors in adults with T2D. In this pilot study, sixteen adults aged 20 to 70 years with insulin-independent T2D for ≤6 years will complete a 12-week controlled-feeding intervention while maintaining their weight. During the ramp-up phase (weeks 1-4), participants progressively consume more whole fruit. During weeks 5 to 12, participants eat a fruit-rich Mediterranean diet providing 50% of calories as whole fruit (∼16.4 servings/day). All outcomes are measured at weeks 0, 4, and 12. The primary outcome is glycemic control, assessed hierarchically by whether participants achieve nondiabetic glucose concentrations without antihyperglycemic medications; the total dose of antihyperglycemic medications; mean glucose during a three-hour oral glucose tolerance test; and mean 24-hour glucose from continuous glucose monitoring. Secondary outcomes include intrahepatic lipid, pancreatic fat, blood pressure, heart rate, and serum lipids. We hypothesize that a fruit-rich diet will improve glycemic control, reduce the need for antihyperglycemic medications, decrease ectopic fat, and improve cardiovascular risk factors. This novel study will help determine the effects of a whole fruit-rich diet on glycemic control and liver fat and whether diabetes remission may be possible without losing weight. This study was registered at ClinicalTrials.gov (NCT03758742).

Low-carbohydrate diets (LCD) have inconclusive impacts on psychological outcomes, quality of life (QoL), and cognition. This study summarised current evidence by searching PubMed/Medline, Scopus, and Web of Sciences until October 2024. Thirty randomised controlled trials (RCTs) were included with a total sample size of 1781 (923 in the LCD group and 853 in the control group). No significant effect of LCD on mood disturbance, depression, anxiety, QoL, or memory speed was found. Subgroup analysis, however, showed significant QoL improvement in subjects consuming ≥15% of energy from carbohydrate, and trials with follow-up over 120 days. Of note, LCD significantly increased QoL in patients with neurological disorders. However, an unfavourable decrease in memory speed was observed in adults older than 55 years, and those consuming ≥15% of energy from carbohydrate. Findings demonstrated contradictory effects of LCD on QoL, mood, mental health, and memory speed.

CRD42023452217.

The dual burden of Type 2 Diabetes Mellitus (T2DM) and obesity is a critical public health issue. Low-carbohydrate diets have emerged as a potential intervention, yet clinical evidence remains inconclusive.

This meta-analysis assesses the impact of low-carbohydrate diets on metabolic profiles in overweight or obese T2DM patients, aiming to guide clinical practice.

A systematic review identified randomized clinical trials (RCTs) comparing low-carbohydrate diets to control diets in T2DM patients from PubMed, Embase, and the Cochrane Library databases up to April 2023.

Seventeen RCTs, encompassing 1,197 participants, demonstrated that low-carbohydrate diets significantly improved HbA1c levels and fasting plasma glucose (mean difference [MD] = -0.36, 95% CI -0.44 to -0.29, p < 0.00001; MD = -10.71, 95% CI -14.39 to -7.03, p < 0.00001). They also reduced triglycerides and increased HDL cholesterol (MD = -19.91, 95% CI -28.83 to -10.99, p < 0.00001; MD = 2.49, 95% CI 1.07-3.91, p = 0.0006), without affecting LDL and total cholesterol. Weight loss, reduced BMI, lower diastolic blood pressure, and decreased waist circumference were additional benefits.

Low-carbohydrate diets may enhance glycemic control and lipid profiles in overweight or obese T2DM patients, warranting consideration in T2DM management. However, the variability in diet definitions and methodologies underscores the necessity for further research to standardize dietary guidelines and evaluate long-term effects.

This systematic review evaluates the comparative efficacy of low-carbohydrate diets (LCDs) versus low-fat diets (LFDs) in improving glycemic control, weight management, and lipid profiles in individuals with type 2 diabetes mellitus (T2DM) or prediabetes. Seven randomized controlled trials involving diverse populations were included, with dietary interventions ranging from very low-carbohydrate ketogenic (LCK) diets (typically <10% of total caloric intake from carbohydrates, with higher fat and moderate protein) to moderate carbohydrate regimens (30-45% of total calories). LFDs, in contrast, prioritized carbohydrate intake (50-60% of total calories), with reduced fat (<20-30%) and moderate protein (15-20%). Across studies, LCDs consistently demonstrated greater reductions in HbA1c, fasting glucose, and triglycerides, alongside superior weight loss and increased high-density lipoprotein cholesterol compared to LFDs. Additionally, LCDs were associated with significant reductions in diabetes medication use, highlighting their potential to decrease pharmacological dependency and improve metabolic outcomes, including enhanced insulin sensitivity and reduced inflammation. Despite variability in long-term outcomes and adherence, LCDs emerged as a promising alternative to traditional dietary approaches for managing T2DM. Further research is warranted to explore strategies to improve dietary adherence, such as behavioral interventions and technological support, and to evaluate long-term sustainability, including their effects on cardiovascular health and quality of life. These findings underscore the transformative potential of LCDs in diabetes management and highlight the need for personalized dietary approaches.

Background/Objectives. The ketogenic diet has emerged as a potential treatment strategy for reducing inflammation. The purpose of this meta-analysis and systematic review is to look into how a ketogenic diet affects inflammatory biomarkers in persons who are overweight or obese. Methods. We conducted an extensive search of Web of Science, PubMed, Scopus, and Google Scholar to find pertinent studies reporting changes in inflammatory biomarkers such as C-reactive protein (CRP), the erythrocyte sedimentation rate, and cytokines after a ketogenic diet. Results. Seven randomized controlled trials involving 218 overweight or obese individuals who followed a ketogenic or control diet over 8 weeks to 2 years were included in the review, and five of those were considered for the meta-analysis. The primary outcomes were CRP and IL-6 levels. The results reported significant decreases after treatment for CRP (mean of -0.62 mg/dL (95% CI: -0.84, -0,40), and a slight, but not statistically significant, reduction in IL-6 (mean of -1.31 pg/mL (95% CI: -2.86, 0.25). Conclusions. The ketogenic diet could contribute to modulating inflammation in obese and overweight subjects.

While the macronutrient content of a ketogenic diet specifically utilized for childhood epilepsy is clearly defined in the literature, variations among other ketogenic diets exhibit substantial heterogeneity. Furthermore, studies utilizing ketogenic diets contain several confounders with notable impacts on outcomes, thereby rendering both their findings and those of the meta-analyses less reliable. The objective of this meta-epidemiological assessment was to scrutinize existing clinical trials that investigated the effects of ketogenic diets on patients with obesity and diabetes, thereby determining the feasibility of conducting a meta-analysis. The Ovid Medline, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase databases were searched from 1946 to 24 September 2024. Of the studies reviewed, none met the predefined inclusion criteria. However, seven articles met these criteria very closely. In the future, studies investigating the effects of ketogenic diets containing significant confounding factors should adopt a single definition of a ketogenic diet. Additionally, accurate measurement of actual macronutrient and caloric intake, along with regularly monitored nutritional ketosis, will be essential to highlight the true effects of a ketogenic diet.

Diabetes is a metabolic disease characterized by hyperglycemia due to impaired insulin secretion, activity, or both. Carbohydrate counting, known for optimal metabolic control, plays in the therapeutic strategy in diabetes. In the last decade, an increasing amount of research has been conducted on carbohydrate counting, and the literature on this topic has been published in academic journals. This bibliometric analysis aimed to comprehensively review and analyze publications from this period, shedding light on trends, developments, and key contributors. The Expanded Science Citation Index published by the Institute for Scientific Information Web of Science, which covers English-language articles published from 1993 to 2024, was used. We selected "carbohydrate counting", "carbohydrate count", "carbohydrate counts", "carbohydrate counts", and similar words as "TOPIC" to search for related articles. All basic information about each article were collected, including authors, countries, citations, and keywords. The findings emphasized the need for continued research in this area and to learn more about studies showing the relationship between carbohydrate counting and the pathophysiology of diabetes, treatment, complications, and technologies. This analysis summarizes the general trends and key findings of research on carbohydrate counting over the past years and provides guidance for future research.

Type 2 diabetes mellitus (T2DM) is a prevalent chronic metabolic disorder characterized by insulin resistance and progressive beta cell dysfunction, presenting substantial global health and economic challenges. This review explores recent advancements in diabetes management, emphasizing novel pharmacological therapies and their physiological mechanisms. We highlight the transformative impact of Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) and Glucagon-Like Peptide 1 Receptor Agonist (GLP-1RA), which target specific physiological pathways to enhance glucose regulation and metabolic health. A key focus of this review is tirzepatide, a dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors. Tirzepatide illustrates how integrating innovative mechanisms with established physiological pathways can significantly improve glycemic control and support weight management. Additionally, we explore emerging treatments such as glimins and glucokinase activators (GKAs), which offer novel strategies for enhancing insulin secretion and reducing glucose production. We also address future perspectives in diabetes management, including the potential of retatrutide as a triple receptor agonist and evolving guidelines advocating for a comprehensive, multifactorial approach to care. This approach integrates pharmacological advancements with essential lifestyle modifications-such as dietary changes, physical activity, and smoking cessation-to optimize patient outcomes. By focusing on the physiological mechanisms of these new therapies, this review underscores their role in enhancing T2DM management and highlights the importance of personalized care plans to address the complexities of the disease. This holistic perspective aims to improve patient quality of life and long-term health outcomes.

The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE).

Eligible participants are between 21 and 80 years of age diagnosed with moderately controlled T2D (HbA1c: 6.0 to 8.0%) and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: (1) Personalized, (2) Standardized, or (3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrient targets to meet Mediterranean diet guidelines, in addition to 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same educational content as those in the UCC arm, following the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, in addition to real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.

The DiaTeleMed Study aims to address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.

ClinicalTrials.gov NCT05046886. Registered on September 16, 2021.

This study was designed to evaluate the impact of VLCKD on cardiovascular risk factors in patients with T2DM.

Until March 2024, extensive searches were conducted on PubMed, Scopus, Web of Science, Embase, and other relevant databases. The purpose was to identify clinical trials examining the impact of VLCKD on glycemic control, lipid profile, and blood pressure. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) method was used to assess the evidence's degree of certainty.

Our initial search found a total of 2568 records and finally 29 trials were included in final analysis. Our results showed that adherence from VLCKD led to significant reduction in fasting blood sugar (WMD= -11.68 mg/dl; 95% CI: -18.79, -4.56; P = 0.001), HbA1c (WMD= -0.29; 95% CI: -0.44, -0.14; P < 0.001), HOMA-IR(WMD= -0.71; 95% CI: -1.14, -0.29; P = 0.001), insulin (WMD= -1.45; 95% CI: -2.54, -0.36; P = 0.009), triglyceride (WMD= -17.95; 95% CI: -26.82, -9.07; P < 0.001), systolic blood pressure (WMD= -2.85, 95% CI: -4.99, -0.71; P = 0.009) and diastolic blood pressure (WMD= -1.40; 95% CI: -2.66, -0.13; P = 0.03). We also found a significant increase in high-density lipoprotein (HDL) level after adherence from VLCKD diet (WMD = 3.93, 95% CI: 2.03, 5.84; P = 0.000). We couldn't find any significant differences between groups in term of LDL and total cholesterol levels.

People following a VLCKD experience a more significant improvement in cardiovascular risk factors when compared to individuals on control diets.

The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately-controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE).

Eligible participants are between 21 to 80 years of age diagnosed with moderately-controlled T2D (HbA1c: 6.0-8.0%), and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: 1) Personalized, 2) Standardized, or 3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrients targets to meet Mediterranean diet guidelines plus 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same education content as UCC on the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, plus real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app.

The DiaTeleMed study will address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level.

The DiaTeleMed Study is registered with ClinicalTrials.gov (Identifier: NCT05046886).

Cardiovascular diseases (CVDs) are major causes of mortality around the world. High blood pressure (BP) or hypertension is one of the most significant predisposing factors to CVDs. Ketogenic diets (KDs) have been the center of attention for their possible health benefits. The aim of this analysis is to study the impact of KDs on BP through the existing literature.

We investigated the impact of KDs on systolic and diastolic blood pressures (SBP and DBP) conducted in the format of randomized controlled trials (RCTs). Four online databases (PubMed/Medline, SCOPUS, Cochrane Library, and Google Scholar) were searched from inception up to November 2022. Subgroup analyses were carried out to find the sources of heterogeneities. Twenty-three RCTs with 1664 participants were identified. KDs did not exert any significant impacts on SBP (WMD: -0.87 mmHg, 95% CI: -2.05, 0.31) nor DBP (WMD: -0.11 mmHg, 95% CI -1.14, 0.93). Subgroup analyses did not reveal any further information. Also, non-linear dose-response analysis could not detect any associations between the percentage of calorie intake from fat in the KD format and BP levels.

KDs do not seem to be effective in improving BP. Nonetheless, further investigations are recommended to examine the proportion of fat intake needed to induce favorable clinical impacts.

Several meta-analyses have found a positive association between a popular type of "fad diet", ketogenic diets, and their effect on anthropometric and blood parameters. However, the non-specific inclusion criteria for meta-analyses may lead to incorrect conclusions. The aim of this literature review is to highlight the main confounders and methodological pitfalls of meta-analyses on ketogenic diets by inspecting the presence of key inclusion criteria. The PubMed, Embase, and Web of Science databases and the Cochrane Database of Systematic Reviews were searched for meta-analyses. Most meta-analyses did not define the essential parameters of a ketogenic diet (i.e., calories, macronutrient ratio, types of fatty acids, ketone bodies, etc.) as inclusion criteria. Of the 28 included meta-analyses, few addressed collecting real, re-measured nutritional data from the ketogenic diet and control groups in parallel with the pre-designed nutritional data. Most meta-analyses reported positive results in favor of ketogenic diets, which can result in erroneous conclusions considering the numerous methodological pitfalls and confounders. Well-designed clinical trials with comparable results and their meta-analyses are needed. Until then, medical professionals should not recommend ketogenic diets as a form of weight loss when other well-known dietary options have been shown to be healthy and effective.

Carbohydrate-restricted diets are widely used as an effective treatment tool for many chronic diseases. The impact of these diets on physical health is well known, but their impact on psychological health is less well described in the scientific literature. This is an important aspect to focus on, especially if the diets are to be sustainable in the long term.

The objective of this study was to systematically review the scientific literature describing the effect of carbohydrate-restricted diets and ketogenic diets on psychological outcomes, as observed in randomized controlled trials. Additionally, the potential synergistic effect of carbohydrate-restricted diets and exercise or social factors on these outcomes was researched.

Five databases (Web of Science, PubMed, Scopus, ScienceDirect, and MEDLINE Complete) were searched without restriction of publication date.

The first data extraction was made in October 2020 and the second in May 2022. Abstract screening was performed by 3 independent reviewers. The quality of studies was assessed using the Jadad scale.

Sixteen randomized controlled studies were included in the analysis. Five studies focused on clinical populations, 9 on obese/overweight populations, and 2 on healthy populations; all studies examined adult people. Four psychological outcomes were identified (quality of life, mental health, mood, and fatigue), and they were examined in connection with a very low-carbohydrate or ketogenic diet.

Daily low-carbohydrate intake may not negatively affect psychological well-being, and low-carbohydrate diets and ketogenic diets are no worse than other diets in this respect. An intervention of 12 weeks or longer can bring benefits in psychological well-being. The synergistic effect of diet and exercise or social factors was not reviewed due to lack of evidence.

The worldwide prevalence of type 2 diabetes mellitus (T2DM) and obesity has been steadily increasing over the past four decades, with projections indicating a significant rise in the number of affected individuals by 2045. Therapeutic interventions in T2DM aim to control blood glucose levels and reduce the risk of complications. Dietary and lifestyle modifications play a crucial role in the management of T2DM and obesity. While conventional medical nutritional therapy (MNT) often promotes a high-carbohydrate, low-fat Mediterranean diet as an elective treatment, low-carbohydrate diets (LCDs), specifically those restricting carbohydrate intake to less than 130 g/day, have gained popularity due to their multifaceted benefits. Scientific research supports the efficacy of LCDs in improving glycemic control, weight loss, blood pressure, lipid profiles, and overall quality of life. However, sustaining these benefits over the long term remains challenging. This trial aimed to compare the effects of a Mediterranean diet vs. a low-carbohydrate diet (carbohydrate intake < 130 g/day) on overweight/obese patients with T2DM over a 16-week period. The study will evaluate the differential effects of these diets on glycemic regulation, weight reduction, lipid profile, and cardiovascular risk factors.

The study population comprises 100 overweight/obese patients with poorly controlled T2DM. Anthropometric measurements, bioimpedance analysis, and blood chemistry assessments will be conducted at baseline and after the 16-week intervention period. Both dietary interventions were hypocaloric, with a focus on maintaining a 500 kcal/day energy deficit.

After 16 weeks, both diets had positive effects on various parameters, including weight loss, blood pressure, glucose control, lipid profile, and renal function. However, the low-carbohydrate diet appears to result in a greater reduction in BMI, blood pressure, waist circumference, glucose levels, lipid profiles, cardiovascular risk, renal markers, and overall metabolic parameters compared to the Mediterranean diet at the 16-week follow up.

These findings suggest that a low-carbohydrate diet may be more effective than a Mediterranean diet in promoting weight loss and improving various metabolic and cardiovascular risk factors in overweight/obese patients with T2DM. However, it is important to note that further research is needed to understand the clinical implications and long-term sustainability of these findings.

Diabesity, the intersection of obesity and diabetes, presents a global health crisis with profound implications. Addressing diabesity requires multifaceted strategies, with diet playing a pivotal role. Over the last 15 years, clinical studies have intensified their exploration of various dietary approaches in diabesity management. This literature review aims to synthesize findings from clinical studies conducted in the last 15 years, shedding light on the efficacy, mechanisms, and nuances of different diet types in diabesity management with special focus on the Mediterranean diet (MD).

Thorough research of academic databases yielded a collection of relevant clinical studies. These studies encompassed a range of dietary strategies, including the MD, low-carbohydrate diets, plant-based diets, high-protein diets, low-fat regimens, and intermittent fasting. Key findings, methodologies, and outcomes were thoroughly extracted and analyzed.

The last 15 years have witnessed considerable improvements in recognizing the role of human nutritional habits in diabesity management. The MD appears to be the most well-recognized diet, exerting favorable effects against both obesity and diabetes. Low-carbohydrate diets were found to enhance glycemic regulation and decrease insulin resistance. Plant-based diets demonstrated potential benefits in weight management and cardiometabolic health. High-protein, low-fat dietary models exhibited positive effects on satiety and body weight decline. Intermittent fasting regimens also exerted metabolic improvements and body weight decline. Personalization emerged as a crucial factor in dietary recommendations.

Clinical studies from the last 15 years underscore the intricate relationship between diet types and diabesity management. The above results contribute to an increasing body of evidence, emphasizing the need for tailored dietary approaches and especially the MD. Healthcare providers can utilize this knowledge to offer personalized dietary recommendations for individuals with diabesity, potentially curbing the rise of these twin epidemics and improving the well-being of affected populations.

To systematically review the effects of the ketogenic diet on glycaemic control, body weight, cardiovascular risk factors, and liver and kidney function in patients with type 2 diabetes.

PubMed, MEDLINE, Embase, Cochrane Library and CINAHL were searched for randomised controlled trials published between 2001 and 2021 that compared the ketogenic diet to a control diet for effects on glycaemic control, body weight, cardiovascular risk factors, liver and renal function markers in adults with type 2 diabetes for >14 days. Meta-analyses using fixed or random effects models were conducted.

Nineteen reports from 11 randomised controlled trials were included. Compared to the control, the ketogenic diet showed no significant difference in changes in glycaemic control or body weight, but greater increases in HDL (standardised mean difference 0.19; 95%CI 0.02-0.37; I2 = 0 %; moderate-quality evidence) and greater reductions in triglycerides (standardised mean difference -0.41; 95%CI -0.64 to -0.18; I2 = 0 %; low-quality evidence).

The ketogenic diet may improve lipid profiles but showed no additional benefits for glycaemic control or weight loss compared to control diets in type 2 diabetes patients over two years.

In 2019, "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report" was published. This consensus report, however, did not provide an easy way to illustrate to subjects with prediabetes (SwPs) how to follow a correct dietary approach. The purpose of this review is to evaluate current evidence on optimum dietary treatment of SwPs and to provide a food pyramid for this population. The pyramid built shows that everyday consumption should consist of: whole-grain bread or potatoes eaten with their skins (for fiber and magnesium) and low glycemic index carbohydrates (GI < 55%) (three portions); fruit and vegetables (5 portions), in particular, green leafy vegetables (for fiber, magnesium, and polyphenols); EVO oil (almost 8 g); nuts (30 g, in particular, pistachios and almonds); three portions of dairy products (milk/yogurt: 300-400 g/day); mineral water (almost 1, 5 L/day for calcium intake); one glass of wine (125 mL); and three cups of coffee. Weekly portions should include fish (four portions), white meat (two portions), protein plant-based food (four portions), eggs (egg portions), and red/processed meats (once/week). At the top of the pyramid, there are two pennants: a green one means that SwPs need some personalized supplementation (if daily requirements cannot be satisfied through diet, vitamin D, omega-3, and vitamin B supplements), and a red one means there are some foods and factors that are banned (simple sugar, refined carbohydrates, and a sedentary lifestyle). Three to four times a week of aerobic and resistance exercises must be performed for 30-40 min. Finally, self-monitoring innovative salivary glucose devices could contribute to the reversion of prediabetes to normoglycemia.

Type 2 diabetes mellitus (T2DM) is one of the most widespread diseases in Western countries, and its incidence is constantly increasing. Epidemiological studies have shown that in the next 20 years. The number of subjects affected by T2DM will double. In recent years, owing to the development and improvement in methods for studying the genome, several authors have evaluated the association between monogenic or polygenic genetic alterations and the development of metabolic diseases and complications. In addition, sedentary lifestyle and socio-economic and pandemic factors have a great impact on the habits of the population and have significantly contributed to the increase in the incidence of metabolic disorders, obesity, T2DM, metabolic syndrome, and liver steatosis. Moreover, patients with type 2 diabetes appear to respond to antihyperglycemic drugs. Only a minority of patients could be considered true non-responders. Thus, it appears clear that the main aim of precision medicine in T2DM is to identify patients who can benefit most from a specific drug class more than from the others. Precision medicine is a discipline that evaluates the applicability of genetic, lifestyle, and environmental factors to disease development. In particular, it evaluated whether these factors could affect the development of diseases and their complications, response to diet, lifestyle, and use of drugs. Thus, the objective is to find prevention models aimed at reducing the incidence of pathology and mortality and therapeutic personalized approaches, to obtain a greater probability of response and efficacy. This review aims to evaluate the applicability of precision medicine for T2DM, a healthcare burden in many countries.

To investigate the effects of a two-meals-a-day energy-restricted ketogenic diet (KD) on newly diagnosed obese patients with type 2 diabetes mellitus. In total, 60 obese patients with newly diagnosed type 2 diabetes mellitus were divided into 2 groups: 1 group followed a 2-meals-a-day KD and the other group followed a conventional diabetic diet. Changes in weight, blood glucose, blood lipids, insulin resistance, and uric acid levels were observed before and after 2 months of adhering to the respective diets under energy restriction. Both groups showed significant reductions in weight, waist circumference, body mass index, total cholesterol, triglycerides, high-density lipoproteins, low-density lipoproteins, fasting blood glucose, fasting insulin, and glycated hemoglobin (P < .05). The twice-daily KD group showed more significant improvements in these parameters compared to the conventional diabetic diet group. In addition, the 2-meals-a-day KD group showed a slight increase in uric acid levels compared to the conventional diabetic diet control group (P < .05). The 2-meals-a-day KD can significantly improve weight, blood glucose, and lipid control in newly diagnosed obese patients with type 2 diabetes mellitus.

To evaluate the effect of basic carbohydrate counting (CC) on HbA1c in Type 2 Diabetes (T2D) patients using oral antidiabetic drugs in the primary care.

The study is a non-randomized controlled clinical trial. T2D patients, aged between 18 and 75 years, HbA1c ≥ 6,5 %, using oral antidiabetic medication, were followed for three months in two groups: one intervention (IG) (n = 33), one control group (CG) (n = 45), in two different Primary Care Centers. General diabetes care was applied in both groups; basic CC training was given additionally to the IG. An informative CC booklet was distributed to both groups. Beside sociodemographic questionnaire, CC knowledge scale was applied to all participants; HbA1c, other laboratory, anthropometric measurements were performed at the beginning and at the 3rd month of the study.

At the third month, HbA1c decreased within the IG from 7.7 % to 7.2 % (p:0.002), from 7.49 % to 7.46 %, in the CG (p:0.851). Comparing groups, the decrease in HbA1c in the IG was higher than in the CG (-0.5, -0.02, p: 0.018). Third month knowledge score was higher the IG's (<0.001).

Basic CC training provided to T2DM patients, improves glycemic control by improving HbA1c and increasing CC knowledge.

Low-carbohydrates diets are increasingly used to treat obesity and metabolic disorders. A very low-carbohydrate, ketogenic diet is hard to follow and, due to the very high fat content, linked to severe side effects, like hyperlipidemia and atherogenesis. Therefore, a less restrictive, unsaturated fat-based low-carbohydrate diet appears as a promising alternative. Since neither sex differences, nor their effect on specific metabolic hormones and adipose tissue compartments have been investigated thoroughly in these diets, we aimed to analyze their dynamics and metabolic factors in mice. We found a significant sexual dimorphism with decreased body weight and subcutaneous fat only in males on ketogenic diet, while diminished insulin, elevated ghrelin and FGF-21 were present with a differential time course in both sexes. The non-ketogenic moderate low-carbohydrate diet increased body weight and perigonadal fat in females, but induced leptin elevation in males. Both diets enhanced transiently TNFɑ only in males and had no impact on behavior. Altogether, these results reveal complex sex-dependent effect of dietary interventions, indicating unexpectedly females as more prone to unfavorable metabolic effects of low-carbohydrate diets.

Despite the evidence supporting the efficacy of the ketogenic diet (KD) on weight and type 2 diabetes (T2D) management, adherence to the KD is challenging. Additionally, no studies have reported changes in PA among individuals with overweight/obesity and T2D who have followed KD. We mapped out the methods used to assess adherence to the KD and level of physical activity (PA) in lifestyle interventions for weight and T2D management in individuals with overweight/obesity and T2D and compared levels of KD adherence and PA in these interventions.

Articles published between January 2005 and March 2022 were searched in MEDLINE, CINAHL, and Scopus. Studies that included KD in lifestyle interventions for adults with T2D and overweight/obesity and measured ketone levels were included.

The eleven included studies comprised eight randomized controlled trials. They mainly used self-reported measures to evaluate adherence to the KD and level of PA. We found studies reported higher carbohydrate intake and lower fat intake than the KD regimen. Great inconsistencies were found among studies on the measurement and reporting of ketone and PA levels.

Our results demonstrated the need to develop intervention strategies to improve adherence to the KD, as well as the necessity of developing standardized diet and PA assessment tools to establish a stronger evidence base for including KD in lifestyle interventions for weight and T2D management among adults with overweight/obesity and T2D.

This Letter reports a new optical fiber gas sensor for measuring breath acetone. The sensor is based on photonic bandgap (PBG) mode laser emission sensing technology using liquid crystal (LC), which is combined with silica fiber and chiral nematic liquid crystal (CNLC), thus providing an ultra-compact, fast-response and simple-to-produce sensing system with a fast response that can accurately and quantitatively determine the concentration of respiratory acetone within the normal oral temperature range (35-38°C). Since LCs are affected by temperature, we propose a method that eliminates the influence of the temperature to solve the problem of the temperature influence when measuring gas. The detection of acetone leads to splitting of the dual laser peaks, with a linear correlation of 0.99. The sensor has a limit of detection of 65 ppm for acetone vapor and thus is suitable for breath acetone detection in diabetic patients.

Optimal carbohydrate intake is an important and controversial area in the nutritional management of type 2 diabetes. Some evidence indicates that reducing overall carbohydrate intake with a low- or very low-carbohydrate eating plan can improve glycemic control compared to following eating plans that involve greater carbohydrate intake. However, critical knowledge gaps currently prevent clear recommendations about carbohydrate intake levels.

The LEGEND (Lifestyle Education about Nutrition for Diabetes) Trial aims to compare a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet for glycemic control in adults with type 2 diabetes. This two-site trial plans to recruit 180 adults with type 2 diabetes. We will randomize participants to either a 20-session group-based diet and lifestyle intervention that teaches either a very low-carbohydrate diet or a moderate-carbohydrate plate-method diet. We will assess participants at study entry and 4 and 12 months later. The primary outcome is HbA1c, and secondary outcomes include inflammation (high sensitivity C-reactive protein), body weight, changes in diabetes medications, lipids (small particle LDL, HDL, triglycerides), skeletal metabolism (bone mineral density from dual-energy x-ray absorptiometry and bone turnover markers serum procollagen type I N propeptide and serum C-terminal telopeptide of type I collagen), and body composition (percent body fat, percent lean body mass).

The LEGEND trial is a randomized controlled trial to assess optimal carbohydrate intake in type 2 diabetes by evaluating the effects of a very low-carbohydrate diet vs. a moderate-carbohydrate plate-method diet over a year-long period. The research addresses important gaps in the evidence base for the nutritional management of type 2 diabetes by providing data on potential benefits and adverse effects of different levels of carbohydrate intake.

ClinicalTrials.gov NCT05237128. Registered on February 11, 2022.

This Letter introduces a novel laser emission probe for liquid-crystal microspheres based on a tapered fiber. A cholesteric liquid crystal (CLC) is injected into a hollow glass microsphere (HGM) attached at the front end of a tapered fiber in order to produce laser. Tapered fibers are preferable to rectangular fibers for liquid-crystal microsphere laser emission. The whispering gallery mode (WGM) laser is significantly suppressed by the tapered fiber-based liquid-crystal microsphere, which also displays an apparent single-mode photonic bandgap (PBG) laser peak. The stimulation response of tapered fiber-based liquid-crystal microspheres to organic vapors causes a modification of the laser peak wavelength with increasing gas concentration. In addition, laser emission generated by tapered fiber-based liquid-crystal microspheres is expected to be used in fields such as microenvironmental biosensing.

The DIETFITS trial reported no significant difference in 12-month weight loss between a healthy low-fat and healthy low-carbohydrate diet. Participants were instructed to restrict fat or carbohydrates to levels consistent with a ketogenic or ultra low-fat diet for 2  months and to subsequently increase intakes until they achieved a comfortable maintenance level.

To compare 3- and 12-month changes in body weight and cardiometabolic risk factors between a subsample of participants who reported 3-month fat or carbohydrates intakes consistent with either a ketogenic-like diet (KLD) or ultra low-fat diet (ULF).

3-month and 12-month weight and risk factor outcomes were compared between KLD (n = 18) and ULF (n = 21) sub-groups of DIETFITS participants (selected from n = 609, healthy overweight/obese, aged 18-50  years).

Less than 10% of DIETFITS participants met KLD or ULF criteria at 3-months. Both groups achieved similar weight loss and insulin resistance improvements at 3-months and maintained them at 12- months. Significant differences at 3-months included a transient ~12% increase in LDL cholesterol (LDL-C) for KLD with a concomitant greater reduction in log(TG/HDL), a measure of LDL-C's atherogenic potential. The latter was maintained at 12-months, despite substantial diet recidivism for both groups, whereas LDL-C levels were similar for ULF at baseline and 12-months. KLD participants achieved and maintained the greatest reductions in added sugars and refined grains at 3- months and 12-months, whereas ULF participants reported a 50% increase in refined grains intake from baseline to 12-months.

Among the ~10% of study participants that achieved the most extreme restriction of dietary fat vs. carbohydrate after 3  months, weight loss and improvement in insulin sensitivity were substantial and similar between groups. At 12  months, after considerable dietary recidivism, the few significant differences in diet quality and blood lipid parameters tended to favor KLD over ULF.

Novel treatment strategies that refract existing treatment algorithms for depressive disorders are being sought. Abnormal brain bioenergetic metabolism may represent an alternative, therapeutically targetable neurobiological basis for depression. A growing body of research points to endogenous ketones as candidate neuroprotective metabolites with the potential to enhance brain bioenergetics and improve mood. Sodium-glucose cotransporter-2 (SGLT2) inhibitors, originally approved for the treatment of diabetes, induce ketogenesis and are associated with mood improvement in population-based studies. In this column, we highlight the rationale for the hypothesis that ketogenesis induced by SGLT2 inhibitors may be an effective treatment for depressive disorders.

A very low-carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain.

This study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring.

The study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5).

Overall, the VLC intervention led to statistically significant improvements in glycemic control (-0.70%, 95% CI -1.04% to -0.35%; P<.001), weight loss (-6.82%, 95% CI -8.57% to -5.08%; P<.001), and depressive symptom severity (Cohen d -0.67, 95% CI -0.92 to -0.41; P<.001). Furthermore, 30% (25/83) of the participants taking metformin at baseline reduced or discontinued their metformin. Only 1 Cohen d point estimate reached 0.5; daily (vs monthly) dietary self-monitoring had a worse impact on depressive symptoms severity (Cohen d=0.47, 95% CI -0.02 to 0.95; P=.06). None of the strategies had a statistically significant effect on outcomes. For changes in our primary outcome, hemoglobin A1c, the daily (vs monthly) dietary self-monitoring impact was 0.42% (95% CI -0.28% to 1.12%); for mindful eating, it was -0.47% (95% CI -1.15% to 0.22%); and for positive affect, it was 0.12% (95% CI -0.57% to 0.82%). Other results for daily (vs monthly) dietary self-monitoring were mixed, suggesting an increase in weight (0.98%) and depressive symptoms (Cohen d=0.47), less intervention satisfaction (Cohen d=-0.20), more sessions viewed (3.02), and greater dietary adherence (Cohen d=0.24). For mindful eating, the results suggested a benefit for dietary adherence (Cohen d=0.24) and intervention satisfaction (Cohen d=0.30). For positive affect, the results suggested a benefit for depressive symptoms (Cohen d=-0.32), the number of sessions viewed (3.68), dietary adherence (Cohen d=0.16), and intervention satisfaction (Cohen d=0.25).

Overall, our results support the use of a VLC diet intervention in adults with T2D. The addition of monthly (not daily) dietary self-monitoring, mindful eating, and positive affect skills training did not show a definitive benefit, but it is worth further testing.

ClinicalTrials.gov NCT03037528; https://clinicaltrials.gov/ct2/show/NCT03037528.

There is mounting interest in the potential efficacy of low carbohydrate and very low carbohydrate ketogenic diets in various neurological and psychiatric disorders.

To conduct a systematic review and narrative synthesis of low carbohydrate and ketogenic diets (LC/KD) in adults with mood and anxiety disorders.

MEDLINE, Embase, PsycINFO and Cochrane databases were systematically searched for articles from inception to 6 September 2022. Studies that included adults with any mood or anxiety disorder treated with a low carbohydrate or ketogenic intervention, reporting effects on mood or anxiety symptoms were eligible for inclusion. PROSPERO registration CRD42019116367.

The search yielded 1377 articles, of which 48 were assessed for full-text eligibility. Twelve heterogeneous studies (stated as ketogenic interventions, albeit with incomplete carbohydrate reporting and measurements of ketosis; diet duration: 2 weeks to 3 years; n = 389; age range 19 to 75 years) were included in the final analysis. This included nine case reports, two cohort studies and one observational study. Data quality was variable, with no high-quality evidence identified. Efficacy, adverse effects and discontinuation rates were not systematically reported. There was some evidence for efficacy of ketogenic diets in those with bipolar disorder, schizoaffective disorder and possibly unipolar depression/anxiety. Relapse after discontinuation of the diet was reported in some individuals.

Although there is no high-quality evidence of LC/KD efficacy in mood or anxiety disorders, several uncontrolled studies suggest possible beneficial effects. Robust studies are now needed to demonstrate efficacy, to identify clinical groups who may benefit and whether a ketogenic diet (beyond low carbohydrate) is required and to characterise adverse effects and the risk of relapse after diet discontinuation.

Healthy eating can improve the course of type 2 diabetes mellitus (T2DM) considerably. As changing eating behaviors in everyday is challenging, there is a need for a nutritional strategy with an eye for everyday life of people with T2DM. A theory centered around the everyday life context is salutogenesis. Salutogenic principles have been operationalized in a new nutritional program for T2DM on food literacy and well-being: the Salutogenic Intervention for Type 2 Diabetes (SALUD) program.

This study aims to describe the protocol of the invention study that will examine the quantitative and qualitative effects of the SALUD program.

A semiblinded randomized controlled trial will be performed in the Netherlands. A sample size of 56 (including a 30% dropout rate) people with T2DM has been calculated, of whom half (n=28, 50%) will follow the SALUD program (intervention) and half (n=28, 50%) will receive usual care (control). Recruitment strategies consist of advertisement via local health care professionals, posters, social media, and local newspapers. The SALUD program consists of 12 weekly web-based group sessions under the supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by selecting a salutogenic coach, use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical salutogenic principle of the intervention is mobilizing 2 important psychosocial resources required for organizing healthy eating in everyday life: self-identity and social support. Measurements will be performed at 3 times: at baseline (T0), after 12 weeks (postintervention; T1), and after 24 weeks (follow-up; T2). The primary outcome is food literacy, measured with the self-perceived food literacy scale questionnaire (expected effect size=0.9). Secondary outcomes are self-efficacy, quality of life, sense of coherence, diet quality, body weight, BMI, and waist-hip ratio. All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of randomized controlled trials. In addition, a qualitative analysis will be performed.

The proposed study will provide useful information on the effects of a salutogenic program on healthy eating and well-being in people with T2DM in everyday life. Recruitment started on October 1, 2021. The intervention participants followed the SALUD program between January and August, 2022. The acquisition of the data was completed on August 1, 2022; publications are expected in 2023.

This study will be one of the first salutogenic interventions for T2DM, which will provide valuable information on what salutogenic intervention entail. The SALUD program may serve as a concrete, web-based tool. The combination of quantitative and qualitative measures allows a comprehensive evaluation of effects. These insights can be used for further optimalization of T2DM interventions.

Netherlands Trial Registry, NL8963; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8963.

DERR1-10.2196/40490.

The study was designed to compare the effects of weight loss induced by a low-carbohydrate-high-fat diet or a normal diet, with and without exercise, on glucose tolerance measured as area under the curve (AUC), and android (A) and gynoid (G) fat distribution. The study was registered at clinicaltrials.gov; NCT04100356. In total, 57 women classified as overweight or obese (age 40 ± 3.5 years, body mass index 31.1 ± 2.6 kg/m²) were randomly assigned and completed a 10-week intervention using a low-carbohydrate high-fat diet or a normal diet, with or without aerobic interval exercise. An equal deficit of 700 kcal/day was prescribed, either restricting the diet only, or moderately restricting diet and including three 50-min high-intensity bicycle sessions per week. There were thus four groups: normal diet (NORM); low-carbohydrate-high-fat diet (LCHF); normal diet with exercise (NORM-EX); and low-carbohydrate-high-fat diet with exercise (LCHF-EX). Linear mixed models was used to assess differences between groups. With all groups pooled, the intervention resulted in a weight loss of 6.7 ± 2.5% (p < 0.001). The intervention did not result in differences between groups in AUC glucose, nor in fasting glucose or indicis for insulin resistance such as Homeostatic Model Assessment, Matsuda Insulin Sensitivity Index, insulinogenic index and disposition index. Post-intervention android fat was lower in LCHF than NORM (3,223 ± 727 vs. 2,533 ± 535 g, p = 0.041). LCHF reached a lower A/G ratio than NORM (0.94 ± 0.12 vs. 1.04 ± 0.09, p = 0.011) and LCHF-EX (0.94 ± 0.12 vs. 1.09 ± 0.09, p < 0.001) after the intervention. LCHF resulted in lower android fat mass compared to NORM and the lowest A/G ratio compared to the other matched groups, but with no accompanying improvement in AUC glucose. In conclusion, although all groups achieved improvements in glucose tolerance, no superior effect was observed with the LCHF diet, neither with nor without exercise.

The exponentially growing frequency of diagnosing diabetes mellitus means that a verification of the previous dietetic approach to treating the disease seems justified. The simultaneous growth of interest in the ketogenic diet and the development of knowledge in this field have contributed to the increasingly frequent application of the ketogenic diet in diabetes treatment. This paper also deals with that issue; its aim includes an extensive analysis of the influence of the ketogenic diet on the prophylaxis and treatment of diabetes. The paper has been prepared based on a wide, meticulous analysis of the available literature on the subject. Among other findings, a favorable effect of that nutrition model has been demonstrated on the values of glycated hemoglobin, glucose, insulin, or other metabolic parameters in diabetes patients. The effect of the ketogenic diet on the pharmacotherapy of type 1 and type 2 diabetes has been presented and compared with the standard nutritional management plan recommended for that disease. Further research is needed in this field, especially studies with a long follow-up period. The discussed articles report interesting therapeutic advantages to the ketogenic diet in comparison with standard diets.

It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.

To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.

6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).

Odense University Hospital in Denmark from November 2016 until June 2020.

165 participants with T2DM.

Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.

Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.

The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A_1c (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.

Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.

Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention.

Novo Nordisk Foundation.

Obesity is considered one of the biggest health problems of the 21st century, becoming a worldwide epidemic, leading to the development of many diseases and increasing the risk of premature death. The first step in reducing body weight is a calorie-restricted diet. To date, there are many different diet types available, including the ketogenic diet (KD) which is recently gaining a lot of attention. However, all the physiological consequences of KD in the human body are not fully understood. Therefore, this study aims to evaluate the effectiveness of an eight-week, isocaloric, energy-restricted, KD as a weight management solution in women with overweight and obesity compared to a standard, balanced diet with the same calorie content. The primary outcome is to evaluate the effects of a KD on body weight and composition. The secondary outcomes are to evaluate the effect of KD-related weight loss on inflammation, oxidative stress, nutritional status, profiles of metabolites in breath, which informs about the metabolic changes in the body, obesity and diabetes-associated parameters, including a lipid profile, status of adipokines and hormones. Notably, in this trial, the long-term effects and efficiency of the KD will be studied. In summary, the proposed study will fill the gap in knowledge about the effects of KD on inflammation, obesity-associated parameters, nutritional deficiencies, oxidative stress and metabolism in a single study. ClinicalTrail.gov registration number: NCT05652972.

Prediabetes is a risk factor for type 2 diabetes mellitus (T2DM). However, it may be reversed via lifestyle changes. Lumen is a novel handheld device that measures exhaled CO2 producing results in agreement with those of indirect calorimetry when assessing metabolic fuel usage. The aim of this study was to examine the effects of following Lumen's personalized, measurement-guided lifestyle intervention program on anthropometric and metabolic variables in adults with prediabetes.

A 12-week single-arm intervention study was conducted in 27 participants. Body composition and blood markers were measured at the start and end of the study. Each participant took a daily morning (fasted) measurement and received feedback on their metabolic state (i.e., their degree of fat vs. carbohydrate oxidation). Participants were then provided with personalized daily guidelines for their carbohydrate, fat, and protein consumption, along with recommended lifestyle changes.

Intention-to-treat analysis revealed a significant decrease in body weight (5.99 kg, p < 0.001), comprising a significant reduction in percentage body fat (2.93%, p < 0.001) and waist circumference (6.23 cm, p < 0.001). Significant reductions were also observed in glycated hemoglobin A1c (0.27%, p < 0.001), triglycerides (0.45 mg/dL, p < 0.001), and systolic blood pressure (0.5 mm Hg, p < 0.05).

In a 12-week pilot study of participants with prediabetes, Lumen usage significantly improved multiple metabolic parameters, demonstrating its potential to deliver better clinical outcomes for patients with T2DM and metabolic syndrome.

Precision nutrition is an emerging concept that aims to develop nutrition recommendations tailored to different people's circumstances and biological characteristics. Responses to dietary change and the resulting health outcomes from consuming different diets may vary significantly between people based on interactions between their genetic backgrounds, physiology, microbiome, underlying health status, behaviors, social influences, and environmental exposures. On 11-12 January 2021, the National Institutes of Health convened a workshop entitled "Precision Nutrition: Research Gaps and Opportunities" to bring together experts to discuss the issues involved in better understanding and addressing precision nutrition. The workshop proceeded in 3 parts: part I covered many aspects of genetics and physiology that mediate the links between nutrient intake and health conditions such as cardiovascular disease, Alzheimer disease, and cancer; part II reviewed potential contributors to interindividual variability in dietary exposures and responses such as baseline nutritional status, circadian rhythm/sleep, environmental exposures, sensory properties of food, stress, inflammation, and the social determinants of health; part III presented the need for systems approaches, with new methods and technologies that can facilitate the study and implementation of precision nutrition, and workforce development needed to create a new generation of researchers. The workshop concluded that much research will be needed before more precise nutrition recommendations can be achieved. This includes better understanding and accounting for variables such as age, sex, ethnicity, medical history, genetics, and social and environmental factors. The advent of new methods and technologies and the availability of considerably more data bring tremendous opportunity. However, the field must proceed with appropriate levels of caution and make sure the factors listed above are all considered, and systems approaches and methods are incorporated. It will be important to develop and train an expanded workforce with the goal of reducing health disparities and improving precision nutritional advice for all Americans.