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

NCT04883515 | Recruiting

• 1 other identifier: 2019/0334/HP
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Insulin Resistance

Keywords

oral glutamine supplementation

Outcome Measures

Primary Outcomes (1)

• Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8

  Week 8

Secondary Outcomes (6)

• 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

• Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16

  Week 16

• Change between feces consistency at baseline and week 8

  Week 8

Study Arms (2)

Oral glutamine supplementation

EXPERIMENTAL

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

Dietary Supplement: Oral glutamine supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation

Oral protein powder supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: Oral protein powder supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation

Interventions

Functional intestinal disorders evaluation PROCEDURE

Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16

Oral glutamine supplementation; Oral protein powder supplementation

Oral protein powder supplementation DIETARY_SUPPLEMENT

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

Oral protein powder supplementation

Insulin-resistance evaluation PROCEDURE

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

Oral glutamine supplementation; Oral protein powder supplementation

Oral glutamine supplementation DIETARY_SUPPLEMENT

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

Oral glutamine supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Hélène LELANDAIS, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Moïse COEFFIER, Pr

  University Hospital, Rouen

  STUDY DIRECTOR

Central Study Contacts

Hélène LELANDAIS, MD

CONTACT

+3323288; helene.lelandaix@chu-rouen.fr

Julien BLOT

CONTACT

+3323288; julien.blot@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: March 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)