The Role of Arginine in Oral Nutritional Supplementation in Preventing or Reducing Complications Following Colorectal Surgery in Patients Who Are Malnourished or at Risk of Malnutrition

The Role of Arginine in Oral Nutritional Supplementation in Preventing or Reducing Complications Following Colorectal Surgery in Patients Who Are Malnourished or at Risk of Malnutrition: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate the role of a high-calorie, high-protein oral nutritional supplement enriched with arginine in the prevention or reduction of post-surgical complications in adult patients undergoing scheduled colorectal surgery who are malnourished or at risk of malnutrition.

The main questions it aims to answer are:

• Does the administration of an arginine-enriched enteral formula decrease the occurrence of post-surgical complications compared to a standard high-protein, high-calorie formula?
• Does the use of an arginine-enriched formula reduce the length of hospital stay and associated healthcare costs?

Researchers will compare a high-protein, high-calorie oral nutritional supplement (ONS) enriched with arginine, omega-3, and nucleotides (Atémpero®) to a standard high-protein, high-calorie ONS without arginine (Diaba plus®) to see if the arginine-enriched formula significantly reduces postoperative complications, such as surgical site infections and dehiscence, as well as the duration of hospital stay.

Participants will:

• Undergo a comprehensive nutritional and clinical assessment, including body composition analysis via bioelectrical impedance and handgrip strength tests.
• Receive individualized oral nutritional supplementation (either the arginine-enriched formula or the standard formula) as part of their preoperative preparation.
• Participate in five follow-up visits (baseline, 24 hours pre-surgery, 24 hours post-surgery, 5 days post-surgery, and 30 days post-surgery) for anthropometric, biochemical, and clinical monitoring.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Surgery; Malnutrition or Risk of Malnutrition
• Intervention / Treatment: Dietary supplement: Atémpero®: An ONS enriched with arginine with no generic equivalent; Dietary supplement: Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent

Detailed Description

Overview This randomized controlled trial (RCT) aims to investigate whether a specific nutritional strategy can improve recovery for adults undergoing scheduled colorectal surgery. Specifically, the study focuses on patients who are malnourished or at risk of malnutrition, a condition affecting 45% to 60% of individuals with colorectal cancer. Malnutrition is a significant concern in surgical settings because it often leads to increased postoperative complications, such as impaired wound healing and higher rates of infection, which ultimately result in longer hospital stays and increased healthcare costs.

Background Maintaining an optimal nutritional status is a critical component of modern surgical protocols, including Enhanced Recovery After Surgery (ERAS). While standard high-protein, high-calorie supplements are frequently used, there is ongoing debate within the medical community regarding the added benefits of "immunonutrients"-specialized ingredients like arginine. Arginine is an amino acid that plays a vital role in collagen synthesis and immune system activation, both of which are essential for proper healing and the prevention of infections. This study seeks to determine if adding arginine to a standard nutritional regimen provides superior outcomes compared to standard supplementation alone.

Methodology

To ensure rigorous results, participants are divided into three distinct groups:

• Control Group: Patients who are well-nourished and do not require specialized supplementation.
• Standard Intervention Group: Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS).
• Arginine-Enriched Group: Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides.

All participants undergo a comprehensive clinical and nutritional assessment. This includes bioelectrical impedance analysis to measure body composition (such as muscle mass, fat percentage, and hydration levels) and handgrip strength tests to evaluate physical function and muscle quality. The study follows a structured timeline involving five key evaluation points:

• Baseline (Visit 0): Initial diagnosis of malnutrition and the start of the personalized nutritional intervention.
• Pre-Surgery (Visit 1): A final check 24 hours before the operation to monitor blood markers and nutritional status.
• Early Post-Surgery (Visits 2 & 3): Monitoring for immediate complications 24 hours and five days after the procedure.
• Long-term Follow-Up (Visit 4): A final assessment 30 days after surgery to evaluate overall recovery and quality of life.

Key Outcomes and Expected Impact The primary objective is to determine if the arginine-enriched formula significantly reduces surgical site infections, suture dehiscence (the reopening of a surgical wound), and other common postoperative issues. Furthermore, the research team is tracking the duration of hospital stays and associated healthcare expenses to evaluate if specialized nutrition is a cost-effective way to improve patient care. Ultimately, these findings could refine clinical guidelines, helping patients recover more quickly and effectively, thereby improving their overall quality of life.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cadiz
    • Algeciras, Cadiz, Spain, 11207
      • Punta Europa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or over.
• Patients due to undergo colorectal surgery.
• Patients who are malnourished or at risk of malnutrition prior to surgery.

Exclusion Criteria:

• Limitations on oral intake (medical conditions, health status, etc.) or contraindications to oral administration.
• Digestive intolerance or allergy to any of the product's components.
• Emergency colorectal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arginine-Enriched Group; Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides.	Dietary supplement: Atémpero®: An ONS enriched with arginine with no generic equivalent; It is a complete, high-protein, high-calorie formula containing a fibre blend enriched with omega-3, L-arginine and nucleotides, and providing vitamin C and zinc. This formula is specifically designed for malnourished patients with wounds or in preparation for surgery. No risks have been identified during the administration of this formula, and it is in line with guidelines for the management of malnourished patients with wounds or those due to undergo colorectal surgery. It is available in a 200 mL format (vanilla flavour). The nutritional information is provided below.
Active Comparator: Standard Intervention Group; Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS).	Dietary supplement: Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent; It is a complete high-protein, high-calorie formula containing a blend of fibre, indicated for malnourished patients with stress-induced hyperglycaemia and/or diabetes who have increased protein and/or energy requirements. No risks have been identified during the administration of this formula. It is available in 200 mL bottles (vanilla, cocoa and coffee flavours).
No Intervention: Control Group; Patients who are well-nourished and do not require specialized supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Postoperative Complications	This dependent variable tracks whether a patient experiences any medical or surgical complications following colorectal surgery. It is recorded as a binary outcome (Yes/No) and serves as the main indicator of the intervention's success in improving patient recovery.	At 24 hours after the procedure and 30 days after surgery.
Surgical Site Infection	An infection occurring at the site of the surgical incision or in the surrounding tissues within the first 30 to 90 days after the procedure. It is assessed using standardized clinical criteria and recorded as Yes or No.	From the date of surgery to 30 or 90 days postoperatively, depending on the procedure.
Postoperative Intestinal Ileus	A temporary failure of the intestines to resume normal muscle contractions (peristalsis) after surgery, which prevents the passage of food and waste. It is recorded as Yes or No based on clinical observation.	At 24 hours after the procedure and 30 days after surgery.
Intra-abdominal Collection (Abscess)	A localized accumulation of pus within the abdominal cavity. It is confirmed by the presence of bacteria in a clinical smear or by positive growth in a bacterial culture. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Intestinal Ischemia	A serious condition occurring when blood flow to the intestines is reduced due to a blockage in a blood vessel, typically an artery, which can lead to tissue damage or death. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Intestinal Evisceration	The protrusion of internal abdominal organs (such as the intestines) through a surgical wound that has reopened across all layers of the abdominal wall following a laparotomy. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Bacteremia	The clinical presence of viable bacteria in the patient's bloodstream, typically identified through blood cultures. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Suture Dehiscence	The failure or reopening of a surgical wound or an internal connection (anastomosis) where tissues were joined by sutures, allowing the edges to separate. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Phlebitis	Inflammation of the walls of a vein, which can occur as a complication of intravenous therapy or the surgical process. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Urinary Tract Infection	An infection occurring in the urinary system (urethra, bladder, or kidneys), common in surgical settings when bacteria enter the urinary tract. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Pneumonia	An infection that inflames the air sacs in one or both lungs, which may fill with fluid or pus, often caused by bacterial or viral infection during the recovery period. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.
Atelectasis	A complete or partial collapse of the lung or a section of the lung, which occurs when the small air sacs (alveoli) become deflated, frequently due to increased intra-abdominal pressure during surgery. Dichotomous qualitative variable: Yes / No.	At 24 hours after the procedure and 30 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological Sex	Classification of the participant as male or female.	At enrollment (baseline).
Age	The chronological age of the participant measured in years at the time of study entry.	At enrollment (baseline).
Clinical Judgment	A professional medical assessment of the patient's current health status. Nominal qualitative variable.	At enrollment (baseline).
Prior Pathologies	A record of pre-existing chronic conditions or previous illnesses. Nominal qualitative variable.	At enrollment (baseline).
Functional Independence	A validated tool (Barthel Index) used to measure a patient's performance in activities of daily living (ADLs). It assesses aspects such as eating, washing, dressing, toilet training and mobility. The score ranges from 0 (total dependence) to 100 (total independence).	At enrollment (baseline) and 30 days after surgery.
Handgrip Strength	A measure of upper body muscle strength and physical function, obtained using a calibrated hydraulic hand dynamometer.	At enrollment (baseline) and 30 days after surgery.
Nutritional status	A standardized screening tool (Malnutrition Universal Screening Tool, MUST) used to identify adults at risk of malnutrition based on Body Mass Index (BMI), unintentional weight loss, and the presence of acute disease.	At enrollment (baseline), 24 hours before the procedure, and 30 days after surgery.
Nutritional Control Index	An objective screening score used to identify the risk of malnutrition based on three laboratory parameters: serum albumin, total cholesterol, and total lymphocyte count. Discrete quantitative variable and categorical qualitative variable: risk of malnutrition (no risk, mild, moderate, severe).	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Malnutrition Diagnosis	A diagnostic framework for malnutrition that requires at least one phenotypic criterion (weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation). Categorical qualitative variable: moderate malnutrition or severe malnutrition.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Fat mass percentage	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Fat-free mass percentage	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total body water	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Phase Angle	A prognostic indicator of cellular health and integrity derived from bioelectrical impedance analysis.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Body Mass Index	A calculation of body fat based on the patient's height and weight, expressed in kg/m².	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Dietary Intake Percentage	A categorical estimation of the amount of prescribed food and supplements consumed, recorded as 25%, 50%, 75%, or 100%.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Intervention Adherence	A record of whether the patient consistently followed the prescribed oral nutritional supplement protocol (Yes/No).	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Type of diet	Diet followed by the participant. Nominal qualitative variable.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Hemoglobin	Measured in g/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Glucose	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Urea	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Creatinine	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Cholesterol	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Triglycerides	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Proteins	Measured in g/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Sodium	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Potassium	Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Total Lymphocyte Count	Measured in cells/µl.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Serum Albumin	Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in g/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Prealbumin	Specific biochemical marker used to evaluate protein status and monitor the effectiveness of nutritional support. Measured in mg/dL.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Hospital Length of Stay	The total number of days the patient remains hospitalized. Discrete numerical variable.	From the day of hospital admission for surgery until discharge.
Healthcare Costs	The direct financial costs associated with their care, used to assess the economic impact of the nutritional intervention. Continuous quantitative variable: economic costs (€ and $).	From the day of hospital admission for surgery until discharge.
Extracellular water	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Intracellular water	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: L.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Cell mass	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Limb muscle mass	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Muscle mass index	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current. Unit: Kg.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.
Moisture content percentage	An assessment of body tissues measured using an Akern BIA 101 device (50kHz), which calculates resistance to a low-intensity electrical current.	At enrollment (baseline), 24 hours before surgery, 5 days after surgery, and 30 days after surgery.

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: Universidad de Granada; Andalusian Health Service

Publications and helpful links

General Publications

• Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3.
• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.
• Liu P, Shen WQ, Chen HL. Efficacy of arginine-enriched enteral formulas for the healing of pressure ulcers: a systematic review. J Wound Care. 2017 Jun 2;26(6):319-323. doi: 10.12968/jowc.2017.26.6.319.
• Barchitta M, Maugeri A, Favara G, Magnano San Lio R, Evola G, Agodi A, Basile G. Nutrition and Wound Healing: An Overview Focusing on the Beneficial Effects of Curcumin. Int J Mol Sci. 2019 Mar 5;20(5):1119. doi: 10.3390/ijms20051119.
• 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.
• Hu WH, Cajas-Monson LC, Eisenstein S, Parry L, Cosman B, Ramamoorthy S. Preoperative malnutrition assessments as predictors of postoperative mortality and morbidity in colorectal cancer: an analysis of ACS-NSQIP. Nutr J. 2015 Sep 7;14:91. doi: 10.1186/s12937-015-0081-5.
• Ellinger S, Stehle P. Efficacy of vitamin supplementation in situations with wound healing disorders: results from clinical intervention studies. Curr Opin Clin Nutr Metab Care. 2009 Nov;12(6):588-95. doi: 10.1097/MCO.0b013e328331a5b5.
• Leon Sanz M. [A critical review of the GLIM criteria]. Nutr Hosp. 2021 Apr 12;38(Spec No1):29-33. doi: 10.20960/nh.03558. Spanish.
• Gomes-Neto AW, van Vliet IMY, Oste MCJ, de Jong MFC, Bakker SJL, Jager-Wittenaar H, Navis GJ. Malnutrition Universal Screening Tool and Patient-Generated Subjective Global Assessment Short Form and their predictive validity in hospitalized patients. Clin Nutr ESPEN. 2021 Oct;45:252-261. doi: 10.1016/j.clnesp.2021.08.015. Epub 2021 Sep 3.
• Osland E, Hossain MB, Khan S, Memon MA. Effect of timing of pharmaconutrition (immunonutrition) administration on outcomes of elective surgery for gastrointestinal malignancies: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):53-69. doi: 10.1177/0148607112474825. Epub 2013 Feb 14.
• Pan YP, Chang PH, Fan CW, Tseng WK, Huang JS, Chen CH, Chou WC, Wang CH, Yeh KY. Relationship between pre-treatment nutritional status, serum glutamine, arginine levels and clinicopathological features in Taiwan colorectal cancer patients. Asia Pac J Clin Nutr. 2015;24(4):598-604. doi: 10.6133/apjcn.2015.24.4.23.
• Bistrian BR. The role of preoperative immune modulating nutrition. Hepatobiliary Surg Nutr. 2020 Apr;9(2):221-222. doi: 10.21037/hbsn.2019.09.16. No abstract available.
• Fujiwara T, Kanazawa S, Ichibori R, Tanigawa T, Magome T, Shingaki K, Miyata S, Tohyama M, Hosokawa K. L-arginine stimulates fibroblast proliferation through the GPRC6A-ERK1/2 and PI3K/Akt pathway. PLoS One. 2014 Mar 20;9(3):e92168. doi: 10.1371/journal.pone.0092168. eCollection 2014.
• Mostafavinia A, Bidram M, Gomi Avili A, Mahmanzar M, Karimifard SA, Sajadi E, Amini A, Hadipour Jahromy M, Ghoreishi SK, Chien S, Bayat M. An improvement in acute wound healing in rats by the synergistic effect of photobiomodulation and arginine. Lab Anim Res. 2019 Dec 11;35:28. doi: 10.1186/s42826-019-0025-x. eCollection 2019.
• Ma C, Tsai H, Su W, Sun L, Shih Y, Wang J. Combination of arginine, glutamine, and omega-3 fatty acid supplements for perioperative enteral nutrition in surgical patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST): A prospective, randomized, double-blind study. J Postgrad Med. 2018 Jul-Sep;64(3):155-163. doi: 10.4103/jpgm.JPGM_693_17.
• Hegazi RA, Hustead DS, Evans DC. Preoperative standard oral nutrition supplements vs immunonutrition: results of a systematic review and meta-analysis. J Am Coll Surg. 2014 Nov;219(5):1078-87. doi: 10.1016/j.jamcollsurg.2014.06.016. Epub 2014 Jun 27. No abstract available.
• Gomez Sanchez MB, Garcia-Talavera Espin NV, Sanchez Alvarez C, Zomeno Ros AI, Hernandez MN, Gomez Ramos MJ, Parra Banos P, Gonzalez Valverde FM. [Perioperative nutritional support in patients with colorectal neoplasms]. Nutr Hosp. 2010 Sep-Oct;25(5):797-805. Spanish.
• Gonzalez-Valverde FM, Vicente-Ruiz M, Gomez-Ramos MJ. Risk factors of anastomotic leakage in colon cancer. Cir Cir. 2019;87(3):347-352. doi: 10.24875/CIRU.18000616.
• Barreiro Dominguez E, Sanchez Santos R, Diz Jueguen S, Pineiro Teijeiro A, Seoane Antelo J, Carrera Dacosta E. [Impact of preoperative oral nutrition therapy in patients undergoing surgery for colorectal cancer]. Nutr Hosp. 2019 Oct 17;36(5):1150-1156. doi: 10.20960/nh.02548. Spanish.
• Manzanares Campillo MDC, Martin Fernandez J, Amo Salas M, Casanova Rituerto D. [A randomized controlled trial of preoperative oral immunonutrition in patients undergoing surgery for colorectal cancer: hospital stay and health care costs]. Cir Cir. 2017 Sep-Oct;85(5):393-400. doi: 10.1016/j.circir.2016.10.029. Epub 2016 Dec 10. Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Immunonutrition; Length of hospital stay; Arginine-enriched oral nutritional supplementation; High-protein, high-calorie formula; Nutritional screening and diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Malnutrition; Colorectal Neoplasms; Disease; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential; Arginine
• Other Study ID Numbers: PEIBA 0655-N-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset containing the collected data, whilst ensuring the anonymity of the participants, will be made publicly available upon publication of the results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No