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

Not Applicable

Not yet recruiting

• Conditions: Obesity; Insulin Resistance
• Interventions: Dietary Supplement: Oral glutamine supplementation; Dietary Supplement: Oral protein powder supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation

• Registration Number: NCT04883515
• Lead Sponsor: University Hospital, Rouen

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19
• Study Start: 2021-06
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral glutamine supplementation	Oral glutamine supplementation	patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
Oral glutamine supplementation	Insulin-resistance evaluation	patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
Oral protein powder supplementation	Oral protein powder supplementation	patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
Oral glutamine supplementation	Functional intestinal disorders evaluation	patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
Oral protein powder supplementation	Insulin-resistance evaluation	patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
Oral protein powder supplementation	Functional intestinal disorders evaluation	patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks

Primary Outcome Measures

Name	Time	Method
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8	Week 8

Secondary Outcome Measures

Name	Time	Method
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16	Week 16
Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16	week 16
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8	Week 8	Francis score will be used
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16	Week 16	Francis score will be used
Change between feces consistency at baseline and week 16	Week 16	bristol scale will be used
Change between feces consistency at baseline and week 8	Week 8	bristol scale will be used

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France