Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04883515

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

Led by University Hospital, Rouen · Updated on 2026-02-06

110

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged from 18 to 65 years
  • Patients with grade II or III obesity (body mass index equal or higher than 35 kg/m2)
  • Patients with insulin resistance (fasting glycaemia between 1.0 g/l and less than 1.26 g/l)
  • Patients with irritable bowel syndrome (Rome IV criteria score 2 or higher)
Not Eligible

You will not qualify if you...

  • Known liver insufficiency (prothrombin time less than 70%)
  • Known kidney failure (glomerular filtration rate less than 60 ml/min)
  • Known intestinal diseases such as inflammatory bowel diseases
  • Vomiting at least once per day during the last 4 weeks
  • Previous bariatric or digestive surgery
  • Use of laxatives or protein powder during the last 4 weeks
  • Ongoing pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rouen University Hospital

Rouen, France, 76031

Actively Recruiting

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Research Team

H

Hélène LELANDAIS, MD

CONTACT

J

Julien BLOT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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