Dietary oleic acid to change cholesterol handling in fat tissue of people with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares dietary enrichment with an oleic-acid–rich oil versus a conventional sunflower oil in adult women with obesity who are scheduled for bariatric surgery. Participants follow the assigned dietary oil regimen prior to surgery, and adipose tissue biopsies collected during the procedure will be analyzed for cholesterol esterification and markers of adipose inflammation. The trial builds on preclinical data suggesting oleic acid can protect white adipose tissue by increasing cholesterol esterification. For this pilot, inclusion is limited to European-origin women aged 18–60 who meet bariatric surgery and insulin-resistance criteria to reduce biological variability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Individual who has given informed consent.

  * Female adult aged between 18 and 60 years (included).
  * Patient with obesity at inclusion, meeting the HAS criteria for bariatric surgery eligibility: BMI ≥ 35 kg/m² associated with a comorbidity or BMI \> 40 kg/m².
  * European origin: For this pilot study, we need to reduce variability factors and focus the research on women of European descent only (having both parents identified by the patient as of European origin).
  * Effective contraception if sexually active, or abstinence, or menopause (criterion required for bariatric surgery).
  * Presenting at inclusion with at least two clinical criteria of insulin resistance according to the definition of the International Diabetes Federation (IDF):

    * Dysglycemia (fasting glucose ≥ 100 mg/dL, glucose intolerance, or type 2 diabetes).
    * Hypertension (≥ 130/85 mm Hg).
    * Low HDL-cholesterol (\< 50 mg/dL).
    * Elevated triglycerides (≥ 150 mg/dL).
  * Affiliated with a social security system or a beneficiary of such a system.
  * Bariatric surgery performed at Nantes University Hospital (CHU de Nantes).

Exclusion Criteria:

* • Modification of diabetes treatment within the past month.

  * Ongoing or planned insulin therapy before bariatric surgery.
  * Modification of lipid-lowering treatment within the past three months.
  * Systemic corticosteroid therapy.
  * Antiviral therapy (HIV).
  * Dietary supplementation affecting lipid metabolism, including proactive margarine, Danacol, polyunsaturated fatty acid supplementation, or any other substance identified by the investigator.
  * Exocrine pancreatic insufficiency.
  * Pregnancy or breastfeeding.
  * History of organ transplantation.
  * Individual deprived of liberty or under legal protection (guardianship or trusteeship).
  * Any clinical condition in which the investigator considers that inclusion in the study may harm the patient's health or compromise the proper conduct of the study.
  * Participation in other clinical trials, except for non-interventional studies and research on surgical techniques or postoperative strategies.

    * Type I, monogenic or secondary diabetes.

Where it's running

• CHU de Nantes
  Nantes, France, France Recruiting

Study contacts

• Principal investigator: Marie De Montrichard, PH — Nantes University Hospital
• Study coordinator: Marie De Montrichard, PH
• Email: marie.dabadie@chu-nantes.fr
• Phone: +332 40 08 30 22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.