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Clinical Trials in Mexico / NCT06883422
Recruiting Not applicable

Pre-Surgical Immunonutrition's Effect on Colorectal Surgery

NCT06883422 · tracked via the Priya Life Science Mexico tracker
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase
Not applicable
Started
2023-05-25
Last updated
2026-03-27

Condition(s) studied

Colorectal Surgery

Investigational drug(s) / intervention(s)

Preoperative oral immunonutrition formulaPreoperative oral Isocaloric and isoproteic polymeric formula

Preoperative oral immunonutrition formula: Intervention 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: Control 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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Both sexes * Over 18 years of age * Scheduled for elective colorectal surgery (Resection and intestinal reconnection) * Obtaining patient consent Exclusion Criteria: * 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 * Documented allergy to any of the ingredients in the formulas under evaluation (milk and/or soy).

Primary outcome measure(s)

  • Concentration of branched-chain amino acids — The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure
    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

Trial sites (1)

FacilityCityRegionStatus
Aurora E Serralde Zúñiga, MD, PhD Mexico City Tlalpan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06883422 on ClinicalTrials.gov ↗ ← All trials in Mexico