Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04883515
NA

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

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-03-01

Completion Date

2026-06

Last Updated

2026-02-06

Healthy Volunteers

No

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

Locations (1)

Rouen University Hospital

Rouen, France