Insulin Resistance, Obesity
Conditions
Keywords
oral glutamine supplementation
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).
Interventions
DIETARY_SUPPLEMENTOral glutamine supplementation
patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
DIETARY_SUPPLEMENTOral protein powder supplementation
patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
PROCEDUREInsulin-resistance evaluation
Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
PROCEDUREFunctional 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
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 | Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Francis score will be used |
| Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16 | Week 16 | Francis score will be used |
| Change between feces consistency at baseline and week 8 | Week 8 | bristol scale will be used |
| Change between feces consistency at baseline and week 16 | Week 16 | bristol scale will be used |
Countries
France
Contacts
CONTACTHélène LELANDAIS, MD
CONTACTJulien BLOT
PRINCIPAL_INVESTIGATORHélène LELANDAIS, MD
University Hospital, Rouen
STUDY_DIRECTORMoïse COEFFIER, Pr
University Hospital, Rouen
Outcome results
None listed