Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Surgery | — | UNRESOLVED | — |
| Malnutrition or Risk of Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atémpero®: An ONS enriched with arginine with no generic equivalent | Dietary Supplement | — | UNRESOLVED |
| Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arginine-Enriched Group
- description
- Malnourished patients receiving a high-protein, high-calorie ONS enriched with arginine, omega-3 fatty acids, and nucleotides.
- interventionNames
- Dietary Supplement: Atémpero®: An ONS enriched with arginine with no generic equivalent
- type
- ACTIVE_COMPARATOR
- label
- Standard Intervention Group
- description
- Malnourished patients receiving a standard high-protein, high-calorie oral nutritional supplement (ONS).
- interventionNames
- Dietary Supplement: Diaba plus®: A high-protein, high-calorie ONS with no generic equivalent
- type
- NO_INTERVENTION
- label
- Control Group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (20)
- BACKGROUNDLeon 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. PMID 33525881
- BACKGROUNDGomes-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. PMID 34620325
- BACKGROUNDOsland 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. PMID 23411423
- BACKGROUNDPan 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. PMID 26693743
- BACKGROUNDBistrian 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. PMID 32355685
- BACKGROUNDFujiwara 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. PMID 24651445
- BACKGROUNDEllinger 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.