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NCT Number: NCT06883422

Pre-Surgical Immunonutrition's Effect on Colorectal Surgery

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aurora E Serralde Zúñiga, MD, PhD

Mexico City, Tlalpan, 14080, Mexico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Preoperative oral immunonutrition formula

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Concentration of branched-chain amino acids

    Time frame: 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

Secondary outcomes

  1. Concentration of albumin

    Time frame: 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

    Serum concentrations of albumin, expressed in grams per deciliter (g/dL), will be quantified at two distinct time points during the study

  2. Concentration of high-sensitivity C-reactive protein

    Time frame: 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

    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

  3. Mortality

    Time frame: Mortality will be assessed within 30 days post-surgery

    The incidence of death within the study population will be recorded and reported throughout the study period following surgery

  4. Length of stay

    Time frame: Length of stay will be assessed within 30 days post-surgery

    The number of days from the patient's hospital admission to discharge will be recorded and reported during the study period

  5. Hospital readmission

    Time frame: Hospital readmission will be assessed within 30 days post-surgery

    The necessity for rehospitalization after discharge following surgery will be recorded and reported during the study period

  6. Anastomotic dehiscence

    Time frame: Anastomotic dehiscence will be assessed within 30 days post-surgery

    Occurrence of anastomotic dehiscence within the study population following surgery

  7. Surgical site infection

    Time frame: Surgical site infection will be assessed within 30 days post-surgery

    Occurrence of surgical site infection within the study population following surgery

  8. Fistula

    Time frame: Fistula will be assessed within 30 days post-surgery

    Occurrence of fistula within the study population following surgery

  9. Paralytic ileus

    Time frame: Paralytic ileus will be assessed within 30 days post-surgery

    Occurrence of paralytic ileus within the study population following surgery

  10. Postoperative intestinal obstruction

    Time frame: Postoperative intestinal obstruction will be assessed within 30 days post-surgery

    Occurrence of postoperative intestinal obstruction within the study population following surgery

Other outcomes

  1. Weight

    Time frame: 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

    Weight will be measured using a calibrated scale and quantified at two distinct time points during the study and will be reported in kg

  2. Height

    Time frame: The measurement will be conducted 7 days prior to the surgical intervention

    Height will be assessed using a standardized automatic stadiometer and quantified once during the study and will be reported in cm

  3. Body mass index

    Time frame: 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

    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

  4. Muscle mass

    Time frame: 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

    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

  5. Fat mass

    Time frame: 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

    Fat 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

  6. Phase angle

    Time frame: 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

    Phase angle 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 degrees (°)

  7. Muscle strength

    Time frame: 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

    Muscle strength will be measured in the dominant hand using a hand dynamometer following a standardized protocol and quantified at two distinct time points during the study and will be reported in kg

  8. Calf circumference

    Time frame: 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

    Calf circumference will be measured using a standardized, non-stretchable metallic tape with standard anthropometric techniques and quantified at two distinct time points during the study and will be reported in cm

  9. Mid-arm circumference

    Time frame: 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

    Mid-arm circumference will be measured using a standardized, non-stretchable metallic tape with standard anthropometric techniques and quantified at two distinct time points during the study and will be reported in cm

  10. Abdominal distension

    Time frame: The assessment will be conducted on the day of the surgical intervention before the procedure begins.

    Abdominal distension will be recorded through patient self-report and will be reported as presence or absence

  11. Abdominal pain

    Time frame: The assessment will be conducted on the day of the surgical intervention before the procedure begins

    Abdominal pain will be recorded through patient self-report and will be reported as presence or absence

  12. Diarrhea

    Time frame: The assessment will be conducted on the day of the surgical intervention before the procedure begins

    The occurrence of diarrhea will be recorded through patient self-report and will be reported as presence or absence

  13. Nausea

    Time frame: The assessment will be conducted on the day of the surgical intervention before the procedure begins

    The occurrence of nausea will be recorded through patient self-report and will be reported as presence or absence

  14. Vomiting

    Time frame: The assessment will be conducted on the day of the surgical intervention before the procedure begins

    The occurrence of vomiting will be recorded through patient self-report and will be reported as presence or absence

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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