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

Recruiting · NCT04883515 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Rouen

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Obesity

Interventions studied

Functional intestinal disorders evaluationInsulin-resistance evaluationOral glutamine supplementationOral protein powder supplementation

What this trial is about

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).

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Rouen University Hospital - Rouen, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →