NCT04883515Recruiting
Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 7 May 2021
- Start date
- 1 Mar 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Obesity
- NCT number
- NCT04883515
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Mar 2023 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient Previously received bariatric surgery or digestive surgery
Other illness
- Patient with Known liver insufficiency (prothrombin time \< 70%)
- Patient with Known intestinal diseases such as inflammatory bowel diseases
Lab values
- Patient with Known kidney failure (GFR \< 60 ml/mn)
Other
- Vomiting patients (≥ 1/ day) during the last 4 weeks
- Patient Using laxatives or protein powder during the 4 last weeks
- On going Pregnancy
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.