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

Obesity Clinical Trial

— OBEGLUT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04883515
• Other study ID #: 2019/0334/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: September 2024

Study information

• Verified date: May 2021
• Source: University Hospital, Rouen
• Contact: Hélène LELANDAIS, MD
• Phone: +3323288
• Email: helene.lelandaix[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Intestinal Diseases
• Obesity

Intervention

Dietary Supplement:
• Oral glutamine supplementation
patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
• 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
• 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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8		Week 8
Secondary	Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16		Week 16
Secondary	Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16		week 16
Secondary	Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8	Francis score will be used	Week 8
Secondary	Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16	Francis score will be used	Week 16
Secondary	Change between feces consistency at baseline and week 8	bristol scale will be used	Week 8
Secondary	Change between feces consistency at baseline and week 16	bristol scale will be used	Week 16