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

NCT04883515 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-06

No results posted yet for this 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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral glutamine supplementation

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

DIETARY_SUPPLEMENT

Oral protein powder supplementation

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

PROCEDURE

Insulin-resistance evaluation

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

PROCEDURE

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Hélène LELANDAIS, MD · University Hospital, Rouen

  • Moïse COEFFIER, Pr · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883515 on ClinicalTrials.gov