Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorNantes University Hospital

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 volunteers

Qualifiers

• 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

Design model

Parallel

Treatments tested in this trial

  • acid-rich sunflower oil oleic acid

    Other intervention

    Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of sunflower oil rich in oleic acid

  • conventional sunflower oil

    Other intervention

    Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of conventional sunflower oil

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Oleic acid groupExperimental treatment 1 intervention
Group B: Conventional oil group (control group)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
13 weeks +/- 2 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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