Effect of alpha-lipoic acid and Silybum marianum supplementation with a Mediterranean diet on metabolic dysfunction-associated steatosis

Table 1 Clinical characteristics of the patients with metabolic dysfunction-associated steatotic liver disease by group

Parameter	Group A, n = 25	Group B, n = 25	P value
Sex			0.333
Male	5 (20)	8 (32)
Female	20 (80)	17 (68)
Age in years	54.7 + 10.5	54.3 + 11.5	0.229
Weight	82.2 + 16.4	82.1 + 14.2	0.473
BMI	32.8 + 6.9	33.3 + 4.7	0.394
Normal weight	-	-
Overweight	10 (40)	5 (20)
Obesity I	5 (20)	10 (40)
Obesity II	6 (24)	9 (36)
Obesity III	4 (16)	1 (4)
Comorbidities
Diabetes	6 (24)	6 (24)	0.629
High blood pressure	7 (28)	8 (32)	0.758
Hypercholesterolemia	8 (32)	5 (20)	0.333
Hypertriglyceridemia	6 (24)	4 (16)	0.480
Hypothyroidism	2 (8)	2 (8)	0.695
Others	-	-

Data are n (%). BMI: Body mass index.

Table 2 Somatometric characteristics at baseline and at weeks 12 and 24 in the intervention group with metabolic dysfunction-associated steatotic liver disease

SM-ALA + MD	Baseline	12 weeks	24 weeks	P value
Somatometry
Weight in kg	82.2 + 16.4	80.1 + 16.2	78.8 + 16.7	0.393
∆weight	-	-1.7 + 2.9	-2.5 + 3.5	0.388
BMI	32.8 + 6.9	32.5 + 6.8	32.4 + 7.05	0.57
Visceral fat as %	12.4 + 3.4	11.9 + 3.3	11.5 + 3.5	0.045
∆visceral fat	-	-0.54 + 1.6	-0.95 + 2.1	0.268
Total fat as %	41.9 + 10.8	42.0 + 10.5	41.0 + 11.5	0.744
Muscle as %	25.5 + 5.4	26.5 + 22.5	26.6 + 8.6	0.554
Circumference in cm
Umbilical	101.8 + 14.7	95.4 + 22.5	97.4 + 14.5	0.003
Hip	112.8 + 16.2	110.2 + 14.0	109.9 + 14.4	0.248
Waist	99.9 + 15.2	96.3 + 13.4	95.9 + 15.0	0.117
Waist-to-hip ratio	0.88 + 0.8	0.87 + 0.06	0.87 + 0.06	0.206
Elastography
kPa1	6.2 + 2.6	5.9 + 2.3	5.4 + 2.03	0.083
∆kPa	-	-0.29 + 2.9	-0.71 + 1.89	0.33

¹Non-normal distribution. ALA: Alpha-lipoic acid; BMI: Body mass index; MD: Mediterranean diet; SM: Silybum marianum.

Table 3 Biochemical parameters at the baseline and at weeks 12 and 24 in the intervention group with metabolic dysfunction-associated steatotic liver disease

Biochemical parameters	Baseline	12 weeks	24 weeks	P value
Leukocytes in thousands/μL1	7.1 (5.3-13.7)	5.7 (4.5-10)	7.0 (4.7-12)	0.876
Hb in g/dL2	13.4 + 1.3	13.1 + 1.3	13.3 + 1.2	0.101
Platelets in miles/μL2	278 + 52	259 + 59	256 + 57	0.014
TB in mg/dL2	0.54 + 0.24	0.60 + 0.18	0.72 + 0.20	0.002
AST in U/L1	27 (11-49)	25 (20-63)	24 (15-45)	0.201
ALT in U/L1	32 (4-102)	30 (17-81)	25 (17-69)	0.267
ALP in IU/L2	99 + 49	92 + 24	81 + 16	0.205
GGT in U/L1	51 (18-370)	25 (10-130)	28 (12-142)	0.033
TP in g/dL1	7.4 (6.4-8.3)	7.4 (6.6-8.1)	7.4 (7.0-8.3)	0.125
Albumin in g/dL2	4.3 + 0.56	4.3 + 0.28	4.4 + 0.3	0.443
Cholesterol in mg/dL2	202 + 45	191 + 52	184 + 49	0.073
HDL in mg/dL1	44 (23-66)	40 (31-61)	46 (29-168)	0.850
LDL in mg/dL2	123 + 41	113 + 39	110 + 37	0.056
VLDL in mg/dL2	31 + 11	41 + 43	32 + 15	0.663
Triglycerides in mg/dL2	165 + 11	163 + 55	32 + 76	0.987
Glucose in mg/dL1	110 (69-316)	101 (83-200)	115 (91-242)	0.616
Creatinine in mg/dL2	0.77 + 0.16	0.67 + 0.14	0.66 + 0.25	0.223
CRP in mg/L1	4.60 (0.50-1.03)	3.90 (1.80-6.00)	0.51 (0.03-1.40)	0.035
Insulin in mg/L2	16.0 + 9.8	20.0 + 11.0	16.0 + 5.0	0.580
HOMA2	4.8 + 3.0	5.7 + 3.3	5.3 + 2.8	0.230

¹Non-normal distribution [median (range)];

²Normal distribution (mean standard deviation).

Data distribution was evaluated through the Kolmogorov-Smirnov test and homoscedasticity with the Levene’s test. Groups were compared using the Student’s t-test or Wilcoxon test for numerical values, and the χ² test or Fisher’s exact test for the categorical variables. ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CRP: C-reactive protein; GGT: Gamma-glutamyl transferase; Hb: Hemoglobin; HDL: High-density lipoprotein; HOMA: Homeostasis Model Assessment; LDL: Low-density lipoprotein; TB: Total bilirubin; TP: Prothrombin time; VLDL: Very low-density lipoprotein.

Table 4 Somatometric characteristics at baseline and weeks 12 and 24 in the control group with metabolic dysfunction-associated steatotic liver disease

Placebo + MD	Baseline	12 weeks	24 weeks	P value
Somatometry
Weight in kg	82.1 + 14.1	79.3 + 12.6	79.2 + 13.3	0.165
∆weight	-	-1.6 + 3.7	-1.0 + 4.6	0.206
BMI	33.3 + 4.7	32.1 + 4.3	32.2 + 5.0	0.16
Visceral fat as %	11.8 + 2.9	12.1 + 2.9	12.8 + 4.3	0.341
∆visceral fat	-	0.33 + 1.6	0.05 + 1.6	0.624
Total fat as %	44.5 + 7.3	43.0 + 9.6	43.7 + 9.1	0.873
Muscle as %	23.9 + 4.2	25.0 + 6.2	24.0 + 4.1	0.73
Circumference in cm
Umbilical	101.2 + 13.2	98.8 + 11.8	94.1 + 18.7	0.07
Hip	113.0 + 11.3	110.3 + 10.2	109.3 + 11.3	0.182
Waist	98.4 + 12.6	96.4 + 11.8	95.7 + 12.3	0.056
Waist-to-hip ratio	0.87 + 0.7	0.87 + 0.08	0.87 + 0.08	0.876
Elastography
kPa	6.9 + 2.3	6.5 + 2.8	5.9 + 3.1	0.132
∆kPa	-	-0.27 + 2.8	1.13 + 3.4	0.032

BMI: Body mass index; MD: Mediterranean diet.

Table 5 Biochemical parameters at baseline and at weeks 12 and 24 in the control group with metabolic dysfunction-associated steatotic liver disease

Biochemical parameters	Baseline	12 weeks	24 weeks	P value
Leukocytes in thousands/μL1	6.6 (4.1-9.5)	6.3 (4-9.6)	7.7 (4.2-9.9)	0.050
Hb in g/dL2	13.1 + 1.4	13.0 + 1.3	12.9 + 2.3	0.071
Platelets in miles/μL2	278 + 73	254 + 59	251 + 50	0.107
TB in mg/dL2	0.52 + 0.32	0.65 + 0.40	0.72 + 0.33	0.001
AST in U/L1	24 (12-148)	29 (18-110)	25 (17-75)	0.185
ALT in U/L1	30 (10-137)	30 (15-97)	28 (18-86)	0.644
ALP in IU/L2	101 + 41	86 + 30	38 + 18	0.011
GGT in U/L1	36 (19-198)	26 (11-152)	72 (28-98)	0.160
TP in g/dL1	7.3 (6.3-8.8)	7.4 (6.6-8.8)	7.7 (6.7-8.9)	0.661
Albumin in g/dL2	4.00 + 0.57	4.20 + 0.59	7.50 + 0.52	0.056
Cholesterol in mg/dL2	195 + 51	203 + 39	185 + 39	0.457
HDL in mg/dL1	44 (23-66)	44 (32-70)	48 (27-95)	0.213
LDL in mg/dL2	125 + 53	128 + 37	110 + 35	0.425
VLDL in mg/dL2	31.0 + 14.0	29.0 + 10.0	27.0 + 9.6	0.041
Triglycerides in mg/dL2	151 + 67	145 + 51	138 + 48	0.116
Glucose in mg/dL1	104 (71-175)	91 (81-148)	108 (90-177)	0.332
Creatinine in mg/dL2	0.76 + 0.21	0.66 + 0.13	0.69 + 0.20	0.233
CRP in mg/L1	2.70 (0.40-1.45)	0.80 (0.70-0.90)	0.27 (0.03-3.10)	0.018
Insulin in mg/L2	8.8 + 6.7	20.0 + 10.0	15.9 + 6.2	0.015
HOMA2	5.6 + 4.6	5.1 + 3.0	4.1 + 1.9	0.497

¹Non-normal distribution [median (range)];

²Normal distribution (mean standard deviation).

Data distribution was evaluated through the Kolmogorov-Smirnov test and homoscedasticity with the Levene’s test. Groups were compared using the Student’s t-test or Wilcoxon test for numerical values, and the χ² test or Fisher’s exact test for the categorical variables, correspondingly. Data distribution was evaluated through the Kolmogorov-Smirnov test and homoscedasticity with the Levene’s test. Groups were compared using the Student’s t-test or Wilcoxon test for numerical values, and the χ² test or Fisher’s exact test for the categorical variables, correspondingly. ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CRP: C-reactive protein; GGT: Gamma-glutamyl transferase; Hb: Hemoglobin; HDL: High-density lipoprotein; HOMA: Homeostasis Model Assessment; LDL: Low-density lipoprotein; TB: Total bilirubin; TP: Prothrombin time; VLDL: Very low-density lipoprotein.