Oral glutamine for improving insulin resistance and IBS symptoms in obese adults
Official title: Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
Run by University Hospital, Rouen · NCT04883515 · Data updated 2026-11-12
This trial will test whether eight weeks of daily oral glutamine supplements can improve blood sugar control and reduce irritable bowel symptoms in adults with obesity and insulin resistance.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT04883515 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with class II or III obesity (BMI ≥35 kg/m2), fasting glycaemia between 1.0 and 1.26 g/L indicating insulin resistance, and IBS meeting Rome IV criteria are the intended participants.
✕Probably not a fit
Patients with significant liver or kidney impairment, inflammatory bowel disease, recent vomiting, prior bariatric or other digestive surgery, recent use of laxatives or protein powders, or pregnancy are excluded and may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll obese adults with insulin resistance and IBS and randomize them in a blinded design to receive either oral glutamine or a protein powder placebo for eight weeks. The trial will include 55 participants per arm and monitor changes in glycemic control and IBS symptoms using standard clinical measures. The study is grounded in evidence that glutamine can support intestinal barrier function and may thereby influence metabolic and gut symptoms. Outcomes will include fasting glucose/insulin measures for insulin resistance and validated symptom scores for functional intestinal disorders.
Why it matters
Potential benefit: If successful, participants might experience better blood sugar control and fewer IBS symptoms from a simple, low-risk oral supplement.
How similar studies have gone: Preclinical work and some small clinical reports suggest glutamine can restore gut barrier function, but randomized trials targeting obese, insulin-resistant patients with IBS are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Rouen University Hospital
Rouen, France Recruiting
Study contacts
- Principal investigator: Hélène LELANDAIS, MD — University Hospital, Rouen
- Study coordinator: Hélène LELANDAIS, MD
- Email: helene.lelandaix@chu-rouen.fr
- Phone: +3323288
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.