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NCT Number: NCT04883515

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

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).

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Location status: Recruiting

Location contact

André PETIT, Dr

SUB_INVESTIGATOR

Eglantine FERRAND-DEVOUGE, Dr

SUB_INVESTIGATOR

Hélène LELANDAIS, MD

CONTACT

[email protected]

+3323288 ext. 9065

Hélène LELANDAIS, MD

PRINCIPAL_INVESTIGATOR

Marie-Pierre TAVOLACCI, Dr

SUB_INVESTIGATOR

Moïse COEFFIER, Dr

SUB_INVESTIGATOR

Najate ACHAMRAH, Dr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glutamine supplementation

Dietary Supplement

patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks

Oral protein powder supplementation

Dietary Supplement

patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks

Insulin-resistance evaluation

Procedure

Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16

Functional intestinal disorders evaluation

Procedure

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 outcomes

  1. Change between Homeostasic model assessment of insulin resistance test value at baseline and week 8

    Time frame: Week 8

Secondary outcomes

  1. Change between Homeostasic model assessment of insulin resistance test value at baseline and week 16

    Time frame: Week 16

  2. Change between Homeostasic model assessment of insulin resistance test value at Week 8 and week 16

    Time frame: week 16

  3. Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 8

    Time frame: Week 8

    Francis score will be used

  4. Change between Irritable Bowel Syndrome (IBS) severity score at baseline and week 16

    Time frame: Week 16

    Francis score will be used

  5. Change between feces consistency at baseline and week 8

    Time frame: Week 8

    bristol scale will be used

  6. Change between feces consistency at baseline and week 16

    Time frame: Week 16

    bristol scale will be used

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène LELANDAIS, MD

CONTACT

[email protected]

+3323288 ext. 9065

Julien BLOT

CONTACT

[email protected]

+3323288 ext. 8265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: OBEGLUT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2021
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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