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

NCT ID: NCT04883515

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral glutamine supplementation

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

Group Type: EXPERIMENTAL

Oral glutamine supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Insulin-resistance evaluation

Intervention Type: PROCEDURE

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

Functional intestinal disorders evaluation

Intervention Type: 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 protein powder supplementation

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

Group Type: ACTIVE_COMPARATOR

Oral protein powder supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Insulin-resistance evaluation

Intervention Type: PROCEDURE

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

Functional intestinal disorders evaluation

Intervention Type: 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

Interventions

Oral glutamine supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Oral protein powder supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Insulin-resistance evaluation

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hélène LELANDAIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Moïse COEFFIER, Pr

Role: STUDY_DIRECTOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Central Contacts

Hélène LELANDAIS, MD

Role: CONTACT

helene.lelandaix@chu-rouen.fr

+3323288 ext. 9065

Julien BLOT

Role: CONTACT

julien.blot@chu-rouen.fr

+3323288 ext. 8265

Facility Contacts

Hélène LELANDAIS, MD

Role: primary

helene.lelandais@chu-rouen.fr

+3323288 ext. 9065

Other Identifiers

2019/0334/HP

Identifier Type: -

Identifier Source: org_study_id