Randomized Clinical Trial
Copyright ©The Author(s) 2024.
World J Gastrointest Surg. Jun 27, 2024; 16(6): 1765-1774
Published online Jun 27, 2024. doi: 10.4240/wjgs.v16.i6.1765
Table 1 The study formula (once peptide) at concentration of 1 kcal:1 mL

Peptide-based formula
Standard formula
Caloric distribution (Protein: Carbohydrate: Fat)20:45:3520:52:28
Source of proteinWhey protein hydrolysate (96%); Leucine (4%)Sodium caseinate (8%); Soy protein isolate (92%)
Source of carbohydrateMaltodextrin (79%); Potato starch (21%)Maltodextrin (64%); Sucrose (32%); Fructo-oligosaccharide (4%)
Source of fatFish oil (5%); Canola oil (43%); MCT oil (52%)Rice bran oil (92%); MCT oil (8%)
Osmolality (mOsm/kg H2O)290364
Osmolarity (mOsm/L)242307
Table 2 Baseline characteristics of study participants, n (%)/mean ± SD

Peptide-based formula (n = 9)
Standard formula
(n = 10)
P value
Demographic
Age (yr)60.1 ± 21.649.1 ± 26.00.333
Gender (Male)7 (77.8)9 (90.0)0.466
Weight (kg)66.2 ± 14.362.6 ± 10.40.533
BMI (kg/m2)24.2 ± 3.122.4 ± 3.80.275
GCS score10.7 ± 3.010.0 ± 3.10.864
SOFA score4.0 ± 2.04.2 ± 2.00.769
1Nutrition status assessment
Risk of malnutrition4 (44.4)3 (30.0)0.752
Mild malnutrition4 (44.4)5 (50.0)
Moderate malnutrition0 (0.0)1 (10.0)
Severe malnutrition1 (11.1)1 (10.0)
Biochemistry
Hemoglobin (g/dL)9.8 ± 2.410.1 ± 1.80.793
White blood cells count (× 103/μL)14.8 ± 4.215.0 ± 7.50.955
Platelets count (× 103/μL)218.8 ± 112.7175.5 ± 85.50.253
Neutrophils84.3 ± 8.583.5 ± 5.80.826
Monocytes6.3 ± 3.57.2 ± 3.80.513
Total lymphocytes count (cell/μL)1267.1± 1164.81006.0 ± 1005.60.288
Blood urea nitrogen (mg/dL)22.3 ± 8.721.3 ± 20.60.327
Creatinine (mg/dL)1.1 ± 0.41.0 ± 0.90.102
Urine urea nitrogen12.0 ± 6.415.4 ± 22.20.441
GFR (mL/min/1.73 m²)74.7± 31.6103.5 ± 35.80.082
Fasting plasma glucose (mg/dL)128.0 ± 26.7128.1 ± 49.10.374
Alkaline phosphatase (U/L)92.1 ± 41.296.3 ± 64.60.859
Aspartate transaminase (U/L)84.5 ± 52.0104.3 ± 66.50.501
Alanine transaminase (U/L)32.5 ± 26.086.8 ± 99.80.154
Nutritional status
Albumin (g/dL)2.6 ± 0.62.5 ± 0.50.821
Prealbumin (mg/dL)10.2 ± 5.314.1 ± 8.20.236
Retinol binding protein (mg/dL)2.1 ± 1.72.0 ± 1.31.000
Table 3 Subject characteristics
Subject number
Cause of ICU admission
Type of surgery
1Traumatic subdural hematomaNon operative management, close neurological observation
2Acute calculus cholecystitis, adult respiratory distress syndromeOpen cholecystectomy
3Closed fracture of shaft of right of humerus, closed fracture of right tibia and fibula severe head injury, maxillofacial injury, traumatic subdural hematomaOpen reduction of fracture with internal fixation humerus. Closed reduction of fracture without internal fixation tibia and fibula. Non operative management, close neurological observation
4AAST grade II liver injury severe head injury, traumatic subdural hematoma thoracic blunt aortic injuryCraniotomy, tracheostomy, thoracic endovascular repair of the aorta
5Splenic injury grade 5 left hemothoraxExploratory laparotomy with splenectomy
6Large gastric ulcer perforationExploratory laparotomy, simple suture with omental patch
7Omental twist causing omental infarctionExploratory laparotomy, omentectomy with drainage
8Sigmoid colon diverticulitis with perforationExploratory laparotomy c sigmoidectomy with Hartmann operation
9Gastric ulcer perforationExploratory laparotomy, simple suture with omental patch
10Traumatic subdural hematomaCraniotomy
11AAST grade 4 pancreatic injuryExploratory laparotomy, distal pancreatectomy, total splenectomy
12Malignant neoplasm of adrenal gland, gallstoneUnilateral adrenalectomy, total cholecystectomy
13Acute calculus cholecystitisLaparoscopic cholecystectomy
14Closed fracture of acetabulum, fracture of right radius and ulnar bonesOpen reduction of fracture with internal fixation of radius and ulnar bones
15Severe head injury, traumatic subdural hematomaCraniectomy for clot removal
16Epidural hematoma, fracture zygoma, fracture orbit, fracture rib with hemothorax rightCraniotomy with clot removal, open reduction with internal fixation facial fractures
17Distal rectal cancerAbdominoperineal resection
18Necrotizing fasciitis with septic shockDebridement right leg
19Necrotizing fasciitis right legDebridement right leg
Table 4 Percentage change of serum fibronectin level, median (25th-75th percentiles)

Peptide-based formula
Standard formula
P value
Day 3 vs Day 117.8 (39.5)17.5 (100.4)0.790
Day 5 vs Day 121.4 (41.9)63.4 (150.4)0.290
Day 11 vs Day 165.1 (106.8)59.1 (211.8)0.641
Day 14 vs Day 111.0 (115.6)80.5 (357.0)0.157
Table 5 Comparison of anthropometry between peptide-based formula and standard formula, mean ± SD
Peptide-based formula
Standard formula
P value (compare between group for day 14)
Day 1
Day 14
P value

Day 1
Day 14
P value

Body weight (kg)66.2 ± 14.365.2 ± 13.10.38962.6 ± 10.458.4 ± 10.50.0370.288
BMI (kg/m2)24.2 ± 3.123.0 ± 2.40.47122.4 ± 3.820.9 ± 4.10.0320.273
SMI (kg/m2)18.4 ± 5.015.7 ± 3.70.13916.1 ± 3.213.6 ± 3.20.0030.419
Table 6 Comparison of duration to achieve goal of calories between peptide-based formula and standard formula, mean ± SD
Day to reach goalPeptide-based formulaStandard formulaP value
Step 1 (25 kcal/kg/d up)2.7 ± 0.63.8 ± 2.50.462
Step 2 (30 kcal/kg/d up)7.5 ± 3.58.5 ± 0.70.733