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

Study Overview
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Brief Summary
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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).

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

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Oral glutamine supplementation
* Dietary Supplement: Oral protein powder supplementation
* Procedure: Insulin-resistance evaluation
* Procedure: Functional intestinal disorders evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral glutamine supplementation<br>patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks | Dietary Supplement: Oral glutamine supplementation<br>* patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks<br>Procedure: Insulin-resistance evaluation<br>* Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16<br>Procedure: Functional intestinal disorders evaluation<br>* Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16<br>|
| Active Comparator: Oral protein powder supplementation<br>patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks | Dietary Supplement: Oral protein powder supplementation<br>* patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks<br>Procedure: Insulin-resistance evaluation<br>* Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16<br>Procedure: Functional intestinal disorders evaluation<br>* Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral glutamine supplementation