Clinical trial NCT06883422: Pre-Surgical Immunonutrition's Effect on Colorectal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colorectal Surgery
Immunonutrition
Enhanced Recovery After Surgery
Preoperative Care
Amino Acids Branched-Chain
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled clinical trial

Sample Size:

For the sample size calculation, it was considered that patients in the immunonutrition intervention group will have a 21% increase in plasma branched-chain amino acid concentration, as reported in the study by Cangiano C et al. Therefore, considering a type 1 error (α) of 0.05 with one tail, and a type 2 error (β) of 0.20, and using the formula N = 2s² (Zα + Zβ)² / Δ², a sample size of 63 subjects per group is obtained.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Patients undergoing colorectal surgery, experience excessive and persistent catabolism, leading to skeletal muscle depletion, and increased inflammatory and immunological involvement, this results in greater malnutrition, mortality, and postoperative morbidity. Depletion of amino acids leads to an increased inflammatory response and diminished immunity. Guidelines of leading international societies in the field of clinical nutrition recommend the perioperative administration of oral formulas with immunonutrients in these patients. The administration of nutritional supplements known as immunonutrition (fortified with arginine, glutamine, branched-chain amino acids (BCAAs) and omega-3 polyunsaturated fatty acids) before gastrointestinal surgery has been shown to improve clinical outcomes, such as a reduction in post-surgical infectious, reduced risk of anastomotic leakage and fewer days of hospital stay; however, the mechanisms related to these benefits are not conclusive.

The aim of the study is to evaluate the effect of preoperative nutritional supplementation for 7 days with a formula enriched with immunonutrients compared to an isocaloric and isoproteic formula, on the plasma concentration of BCAAs in patients undergoing elective colorectal surgery. A randomized, double-blind, controlled trial will be conducted with 63 patients per group. The concentration of BCAAs will be measured prior to the 7 days of nutritional supplementation and will be repeated on the day of the surgical intervention before the procedure. The supplements for both groups will provide 500 calories, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids; the supplement for the intervention group is additionally fortified with immunonutrients. Patients will be instructed to consume the supplement daily for the 7 days prior to the surgical intervention. Patients in both groups will be advised to maintain their usual food intake.

The investigators hypothesized that if an oral formula with immunonutrients is administered compared to an isocaloric and isoproteic formula without them for 7 days in the preoperative period in patients undergoing elective colorectal surgery, there will be an increase in the plasma concentration of BCAAs in the intervention group.

Eligibility criteria: 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 outcomes:
measure: Concentration of branched-chain amino acids
timeFrame: 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
Secondary outcomes:
measure: Concentration of albumin
timeFrame: 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
measure: Concentration of high-sensitivity C-reactive protein
timeFrame: 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
measure: Mortality
timeFrame: Mortality will be assessed within 30 days post-surgery
measure: Length of stay
timeFrame: Length of stay will be assessed within 30 days post-surgery
measure: Hospital readmission
timeFrame: Hospital readmission will be assessed within 30 days post-surgery
measure: Anastomotic dehiscence
timeFrame: Anastomotic dehiscence will be assessed within 30 days post-surgery
measure: Surgical site infection
timeFrame: Surgical site infection will be assessed within 30 days post-surgery
measure: Fistula
timeFrame: Fistula will be assessed within 30 days post-surgery
measure: Paralytic ileus
timeFrame: Paralytic ileus will be assessed within 30 days post-surgery
measure: Postoperative intestinal obstruction
timeFrame: Postoperative intestinal obstruction will be assessed within 30 days post-surgery
Other outcomes:
measure: Weight
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Height
timeFrame: The measurement will be conducted 7 days prior to the surgical intervention
measure: Body mass index
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Muscle mass
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Fat mass
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Phase angle
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Muscle strength
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Calf circumference
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Mid-arm circumference
timeFrame: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement), and the second measurement will be performed on the day of the surgical intervention before the procedure begins
measure: Abdominal distension
timeFrame: The assessment will be conducted on the day of the surgical intervention before the procedure begins.
measure: Abdominal pain
timeFrame: The assessment will be conducted on the day of the surgical intervention before the procedure begins
measure: Diarrhea
timeFrame: The assessment will be conducted on the day of the surgical intervention before the procedure begins
measure: Nausea
timeFrame: The assessment will be conducted on the day of the surgical intervention before the procedure begins
measure: Vomiting
timeFrame: The assessment will be conducted on the day of the surgical intervention before the procedure begins
Locations:
city: Ciudad de México
country: Mexico
facility: Aurora E Serralde Zúñiga, MD, PhD
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aurora E Serralde Zúñiga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li P, Yin YL, Li D, Kim SW, Wu G. Amino acids and immune function. Br J Nutr. 2007 Aug;98(2):237-52. doi: 10.1017/S000711450769936X. Epub 2007 Apr 3.
citation: Choudry HA, Pan M, Karinch AM, Souba WW. Branched-chain amino acid-enriched nutritional support in surgical and cancer patients. J Nutr. 2006 Jan;136(1 Suppl):314S-8S. doi: 10.1093/jn/136.1.314S.
citation: Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
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citation: Adiamah A, Skorepa P, Weimann A, Lobo DN. The Impact of Preoperative Immune Modulating Nutrition on Outcomes in Patients Undergoing Surgery for Gastrointestinal Cancer: A Systematic Review and Meta-analysis. Ann Surg. 2019 Aug;270(2):247-256. doi: 10.1097/SLA.0000000000003256.
citation: Yu K, Zheng X, Wang G, Liu M, Li Y, Yu P, Yang M, Guo N, Ma X, Bu Y, Peng Y, Han C, Yu K, Wang C. Immunonutrition vs Standard Nutrition for Cancer Patients: A Systematic Review and Meta-Analysis (Part 1). JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):742-767. doi: 10.1002/jpen.1736. Epub 2019 Nov 11.
citation: Niu JW, Zhou L, Liu ZZ, Pei DP, Fan WQ, Ning W. A Systematic Review and Meta-Analysis of the Effects of Perioperative Immunonutrition in Gastrointestinal Cancer Patients. Nutr Cancer. 2021;73(2):252-261. doi: 10.1080/01635581.2020.1749291. Epub 2020 Apr 14.
citation: Cangiano C, Laviano A, Meguid MM, Mulieri M, Conversano L, Preziosa I, Rossi-Fanelli F. Effects of administration of oral branched-chain amino acids on anorexia and caloric intake in cancer patients. J Natl Cancer Inst. 1996 Apr 17;88(8):550-2. doi: 10.1093/jnci/88.8.550. No abstract available.