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

Overview

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 supplement Oral glutamine supplementation
  patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
• Dietary supplement Oral protein powder supplementation
  patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
• Procedure Insulin-resistance evaluation
  Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
• 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

Primary outcome measures

• Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 [Time frame: Week 8]

Secondary outcome measures (6)

• Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16 [Time frame: Week 16]
• Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16 [Time frame: week 16]
• Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8 [Time frame: Week 8]
• Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16 [Time frame: Week 16]
• Change between feces consistency at baseline and week 8 [Time frame: Week 8]
• Change between feces consistency at baseline and week 16 [Time frame: Week 16]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 1 center

• Rouen University Hospital — Rouen

Identifiers

NCT: NCT04883515 · 2019/0334/HP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗