Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive.
The objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.
Both sexes
Over 18 years of age
Scheduled for elective colorectal surgery (Resection and intestinal reconnection)
Obtaining patient consent
Consumption of nutritional supplements during the 2 weeks prior to patient enrollment
Consumption of additional nutritional supplements during the 7 days corresponding to the study intervention period
Patients diagnosed with chronic kidney disease
Patients diagnosed with hepatic cirrhosis
Parallel
Preoperative oral immunonutrition formula
Dietary supplementIntervention arm will daily receive, for 7 days, a preoperative oral formula with immunonutrients: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, 11 g of lipids, 5.7 g of glutamine, 7 g of arginine, 3.6 g of leucine, 2.7 g of isoleucine, 3.7 g of valine, and 0.35 g of omega 3
Preoperative oral Isocaloric and isoproteic polymeric formula
Dietary supplementControl arm will daily receive, for 7 days, an isocaloric and isoproteic preoperative oral formula: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids
Concentration of branched-chain amino acids
Plasma concentrations of branched-chain amino acids, expressed in micromoles per liter (µmol/L), will be quantified at two distinct time points during the study
Concentration of albumin
Serum concentrations of albumin, expressed in grams per deciliter (g/dL), will be quantified at two distinct time points during the study
Concentration of high-sensitivity C-reactive protein
Serum concentrations of high-sensitivity C-reactive protein, expressed in milligrams per deciliter (mg/dL), will be quantified at two distinct time points during the study
Mortality
The incidence of death within the study population will be recorded and reported throughout the study period following surgery
Length of stay
The number of days from the patient's hospital admission to discharge will be recorded and reported during the study period
Weight
Weight will be measured using a calibrated scale and quantified at two distinct time points during the study and will be reported in kg
Height
Height will be assessed using a standardized automatic stadiometer and quantified once during the study and will be reported in cm
Body mass index
Body mass index (BMI) will be calculated from the measured weight and height, quantified at two distinct time points during the study and will be reported in kg/m2
Muscle mass
Muscle mass will be evaluated using a standardized tetrapolar bioelectrical impedance analysis and quantified at two distinct time points during the study and will be reported in % of the body weight
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