ObesityOBEGLUTNCT04883515
Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
A study testing Oral glutamine supplementation, Oral protein powder supplementation and Insulin-resistance evaluation in people with Obesity and Insulin Resistance, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Oral glutamine supplementation, Oral protein powder supplementation and Insulin-resistance evaluation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen, 76031
Hélène LELANDAIS, MD, +3323288 ext. 9065, helene.lelandais@chu-rouen.fr
Hélène LELANDAIS, MD
About this study
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).
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Oral glutamine supplementation, Oral protein powder supplementation, Insulin-resistance evaluation, Functional intestinal disorders evaluation
- Keywords
- oral glutamine supplementation
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glutamine supplementationDietary supplement
patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
Oral protein powder supplementationDietary supplement
patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
Insulin-resistance evaluationProcedure or surgery
Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
Functional intestinal disorders evaluationProcedure or surgery
Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16
| Study group | Role | What they receive |
|---|---|---|
| Oral glutamine supplementation | Experimental | patient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks Receives: Dietary Supplement: Oral glutamine supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation |
| Oral protein powder supplementation | Active comparator | patient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks Receives: Dietary Supplement: Oral protein powder supplementation; Procedure: Insulin-resistance evaluation; Procedure: Functional intestinal disorders evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
Measured: Week 8
Secondary outcomes (6)
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16
Measured: Week 16
Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16
Measured: week 16
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8
Francis score will be used
Measured: Week 8
Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16
Francis score will be used
Measured: Week 16
Change between feces consistency at baseline and week 8
bristol scale will be used
Measured: Week 8
Change between feces consistency at baseline and week 16
bristol scale will be used
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Mar 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène LELANDAIS, MD, Principal investigator, University Hospital, RouenMoïse COEFFIER, Pr, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883515
- Sponsor's protocol ID
- 2019/0334/HP
- Acronym
- OBEGLUT
- Status last verified
- Feb 2026
- First submitted
- 7 May 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.
- ClinicalTrials.gov ID
- NCT04883515
- Acronym / sponsor ID
- OBEGLUT / 2019/0334/HP
- Conditions
- Obesity, Insulin Resistance
- Keywords
- oral glutamine supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral glutamine supplementation | Experimental | Dietary Supplement: Oral glutamine supplementation, Procedure: Insulin-resistance evaluation, Procedure: Functional intestinal disorders evaluationpatient will receive Oral glutamine supplementation 10 g Ter In Die during 8 weeks |
| Oral protein powder supplementation | Active comparator | Dietary Supplement: Oral protein powder supplementation, Procedure: Insulin-resistance evaluation, Procedure: Functional intestinal disorders evaluationpatient will receive Oral protein powder supplementation10 g Ter In Die during 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glutamine supplementationpatient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks | Dietary supplement | Oral glutamine supplementation |
| Oral protein powder supplementationpatient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks | Dietary supplement | Oral protein powder supplementation |
| Insulin-resistance evaluationHomeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16 | Procedure or surgery | Oral glutamine supplementation, Oral protein powder supplementation |
| Functional intestinal disorders evaluationFunctional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16 | Procedure or surgery | Oral glutamine supplementation, Oral protein powder supplementation |
Primary outcome
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8
Time frame: Week 8
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène LELANDAIS, MD principal investigator
University Hospital, Rouen
Moïse COEFFIER, Pr study director
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glutamine supplementation, Oral protein powder supplementation and Insulin-resistance evaluation in people with Obesity and Insulin Resistance, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène LELANDAIS, MD (+3323288 ext. 9065, helene.lelandaix@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.