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Clinical Trials in France / NCT04883515
Recruiting Not applicable

Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.

NCT04883515 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Rouen
Phase
Not applicable
Started
2023-03-01
Last updated
2026-02-06

Condition(s) studied

ObesityInsulin Resistance

Investigational drug(s) / intervention(s)

Oral glutamine supplementationOral protein powder supplementationInsulin-resistance evaluationFunctional intestinal disorders evaluation

Oral glutamine supplementation: patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks

Oral protein powder supplementation: patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks

Insulin-resistance evaluation: Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16

Functional intestinal disorders evaluation: Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16

Study summary

Obesity, which has a prevalence at 15% in France, is a major public health concern. Altered glycemic control and irritable bowel syndrome (IBS) are frequently observed in obese patients and lead to reduce the quality of life. In the last decades, the role of gut microbiota and intestinal permeability has been underlined in obesity, glycemic control and IBS. Interestingly, experimental and clinical data show that glutamine, an amino acid, is able to maintain or restore intestinal permeability in different conditions. We thus hypothesize that oral glutamine supplementation may restore gut barrier function contributing to improve glycemic control and IBS-symptoms. Our project will thus aim to evaluate the effects of 8 weeks - oral glutamine supplementation on glycemic control and IBS symptoms in obese patients in a blinded randomized controlled trial. Placebo group will received protein powder. 55 obese patients will enrolled in each arm and will received oral glutamine supplementation or protein powder (10g t.i.d.) during 8 weeks. Blood and feces samples and intestinal permeability assays will be performed at baseline (w0), after 8 weeks of supplementation (w8) and then after 8 weeks of a wash-out period (w16).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged from 18 to 65 years * Patient with h grade II or III obesity (body mass index equal or higher than 35 kg/m2) * Patient with insulino-resistance (fasting glycaemia ≥ 1g/l et \< 1.26 g/l) * Patient with irritable bowel syndrome (Rome IV criteria ≥ 2) Exclusion Criteria: * Patient with Known liver insufficiency (prothrombin time \< 70%) * Patient with Known kidney failure (GFR \< 60 ml/mn) * Patient with Known intestinal diseases such as inflammatory bowel diseases * Vomiting patients (≥ 1/ day) during the last 4 weeks * Patient Previously received bariatric surgery or digestive surgery * Patient Using laxatives or protein powder during the 4 last weeks * On going Pregnancy

Primary outcome measure(s)

  • Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 — Week 8

Trial sites (1)

FacilityCityRegionStatus
Rouen University Hospital Rouen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04883515 on ClinicalTrials.gov ↗ ← All trials in France