Pre-Surgical Immunonutrition's Effect on Colorectal Surgery
Impact of Pre-surgical Oral Immunonutrition on Plasma Levels of Branched-chain Amino Acids in Elective Colorectal Surgery Patients: a Randomized, Double-blind, Controlled, Clinical Trial
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
126 participants
May 25, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Both sexes
- Over 18 years of age
- Scheduled for elective colorectal surgery (Resection and intestinal reconnection)
- Obtaining patient consent
Exclusion Criteria5
- 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).
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Interventions
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06883422