Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients. (OBEGLUT)
Primary Purpose
Obesity, Insulin Resistance
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral glutamine supplementation
Oral protein powder supplementation
Insulin-resistance evaluation
Functional intestinal disorders evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring oral glutamine supplementation
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
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral glutamine supplementation
Oral protein powder supplementation
Arm Description
patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
Outcomes
Primary Outcome Measures
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
Secondary Outcome Measures
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16
Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8
Francis score will be used
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16
Francis score will be used
Change between feces consistency at baseline and week 8
bristol scale will be used
Change between feces consistency at baseline and week 16
bristol scale will be used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883515
Brief Title
Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
Acronym
OBEGLUT
Official Title
Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
oral glutamine supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral glutamine supplementation
Arm Type
Experimental
Arm Description
patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks
Arm Title
Oral protein powder supplementation
Arm Type
Active Comparator
Arm Description
patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral glutamine supplementation
Intervention Description
patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral protein powder supplementation
Intervention Description
patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Insulin-resistance evaluation
Intervention Description
Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
Intervention Type
Procedure
Intervention Name(s)
Functional intestinal disorders evaluation
Intervention Description
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 Measure Information:
Title
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16
Time Frame
Week 16
Title
Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16
Time Frame
week 16
Title
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8
Description
Francis score will be used
Time Frame
Week 8
Title
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16
Description
Francis score will be used
Time Frame
Week 16
Title
Change between feces consistency at baseline and week 8
Description
bristol scale will be used
Time Frame
Week 8
Title
Change between feces consistency at baseline and week 16
Description
bristol scale will be used
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène LELANDAIS, MD
Phone
+3323288
Ext
9065
Email
helene.lelandaix@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène LELANDAIS, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moïse COEFFIER, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène LELANDAIS, MD
Phone
+3323288
Ext
9065
Email
helene.lelandais@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Hélène LELANDAIS, MD
First Name & Middle Initial & Last Name & Degree
Vanessa FOLOPE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
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