NCT04883515

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-05-12
• Last updated: 2026-02-06

Locations

1 site across 1 country: France