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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Oral glutamine supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation; Dietary supplement: Oral protein powder supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène LELANDAIS, MD; Phone Number: 9065 +3323288; Email: helene.lelandaix@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • ROUEN university hospital
    • Contact: Hélène LELANDAIS, MD; Phone Number: 9065 +3323288; Email: helene.lelandais@chu-rouen.fr
    • Principal Investigator: Hélène LELANDAIS, MD
    • Sub-Investigator: Vanessa FOLOPE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral glutamine supplementation; patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks	Dietary supplement: Oral glutamine supplementation; patient will receive oral glutamine supplementation 10 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
Active Comparator: 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; Dietary supplement: Oral protein powder supplementation; patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Francis score will be used	Week 8
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16	Francis score will be used	Week 16
Change between feces consistency at baseline and week 8	bristol scale will be used	Week 8
Change between feces consistency at baseline and week 16	bristol scale will be used	Week 16

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Hélène LELANDAIS, MD, ROUEN university hospital; Study Director: Moïse COEFFIER, Pr, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: oral glutamine supplementation
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Gastrointestinal Diseases; Hyperinsulinism; Insulin Resistance; Intestinal Diseases
• Other Study ID Numbers: 2019/0334/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No