Dietary oleic acid to change cholesterol handling in fat tissue of people with obesity
Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity
This project will test whether adding oleic-acid–rich oil to the diet of women with obesity before bariatric surgery increases cholesterol esterification in their fat tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, France) |
| Trial ID | NCT07027033 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women (18–60 years) of European descent who meet bariatric surgery criteria (BMI ≥ 35 kg/m² with comorbidity or BMI > 40 kg/m²) and have at least two clinical features of insulin resistance.
Not a fit: Men, people of non‑European descent, those not eligible for bariatric surgery, or patients without insulin-resistance features are not eligible and therefore unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, dietary enrichment with oleic acid could reduce adipose tissue inflammation and lower risk of obesity-related cardiometabolic complications.
How similar studies have performed: Preclinical models support the protective effect of oleic acid and human data on oleic-rich diets show cardiometabolic benefits, but using oleic acid specifically to increase adipose cholesterol esterification in bariatric patients is a novel, untested clinical application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nantes, France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.