NCT Number: NCT06883422
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mexico City, Tlalpan, 14080, Mexico
Location status: Recruiting
Adriana G Flores López, MSc
SUB_INVESTIGATOR
Aurora E Serralde Zúñiga, MD, PhD
CONTACT
+52 5554870900 ext. 2193
José F Estrada Moya, MSc
SUB_INVESTIGATOR
Luis E González Salazar, PhD
SUB_INVESTIGATOR
Martha Guevara Cruz, MD, PhD
SUB_INVESTIGATOR
Noel Salgado Nesme, MD
SUB_INVESTIGATOR
Omar Vergara Fernández, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
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
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
Time frame: Anastomotic dehiscence will be assessed within 30 days post-surgery
Occurrence of anastomotic dehiscence within the study population following surgery
Time frame: Surgical site infection will be assessed within 30 days post-surgery
Occurrence of surgical site infection within the study population following surgery
Time frame: Fistula will be assessed within 30 days post-surgery
Occurrence of fistula within the study population following surgery
Time frame: Paralytic ileus will be assessed within 30 days post-surgery
Occurrence of paralytic ileus within the study population following surgery
Time frame: Postoperative intestinal obstruction will be assessed within 30 days post-surgery
Occurrence of postoperative intestinal obstruction within the study population following surgery
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
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
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
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
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
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 (°)
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
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
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
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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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