About this trial
Disruption of white adipose tissue (WAT) homeostasis during obesity is central to the development of associated cardiometabolic complications. Dietary supplementation with oleic acid in obese patients can limit these complications. Experimental data, obtained in preclinical models, suggest that the beneficial effects of oleic acid may protect the TAB by increasing cholesterol esterification. The NAMICO study aims to test this hypothesis using TAB biopsies collected from obese patients undergoing bariatric surgery who had previously undergone dietary enrichment with either a conventional oil or an oil rich in oleic acid.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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).
Disqualifiers
• 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.
Trial design
Parallel
Treatments tested in this trial
acid-rich sunflower oil oleic acid
Other interventionNutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of sunflower oil rich in oleic acid
conventional sunflower oil
Other interventionNutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of conventional sunflower oil
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the effect of consuming oleic acid-rich sunflower oil versus conventional sunflower oil on cholesterol esterification within visceral white adipose tissue.
The primary endpoint of the study is to compare the cholesterol esterification rates in adipocytes between the two experimental groups. This is measured by the ratio of esterified cholesterol (EC) to free cholesterol (FC), expressed as a percentage, determined from samples of visceral adipose tissue collected perioperatively after 13 weeks (± 2 week) of the nutritional supplementation under investigation.
Sponsors and contacts
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