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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral glutamine supplementation | Experimental | patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks |
|
| Oral protein powder supplementation | Active Comparator | patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral glutamine supplementation | Dietary Supplement | patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 | Week 8 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène LELANDAIS, MD | Contact | +3323288 | 9065 | helene.lelandaix@chu-rouen.fr |
| Julien BLOT | Contact | +3323288 | 8265 | julien.blot@chu-rouen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hélène LELANDAIS, MD | University Hospital, Rouen | Principal Investigator |
| Moïse COEFFIER, Pr | University Hospital, Rouen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Recruiting | Rouen | 76031 | France |
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| Oral protein powder supplementation | Dietary Supplement | patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks |
|
| Insulin-resistance evaluation | Procedure | Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16 |
|
| 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 |
|
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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