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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: White Adipose Tissue Inflammation; Obesity; Visceral Adipose Tissue; Subcutaneous Adipose Tissue

Treatments: Other: acid-rich sunflower oil oleic acid; Other: conventional sunflower oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07027033

2024-A02770-47 (Registry Identifier)

RC24_0626

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Oleic acid group

Experimental group

Description:

Female patients undergoing bariatric surgery will be asked to adjust their oleic acid intake through a nutritional, non-pharmacological intervention. This involves the consumption of 40 ml of sunflower oil rich in oleic acid. Of this amount, 30 mL consumed in two portions: one tablespoon (approximately 15 mL) in the morning or at lunch time, and another in the evening. The remaining 10 mL will be used as a substitute for usual dietary fats. This diet will be followed for approximately 13 weeks prior to bariatric surgery.

Treatment:

Other: acid-rich sunflower oil oleic acid

Conventional oil group (control group)

Placebo Comparator group

Description:

Female patients undergoing bariatric surgery will be asked to adjust their dietary intake of sunflower oil. This involves the consumption of 40 ml of sunflower (composition of the sunflow oil only differs fatty acid composition). Of this amount, 30 mL consumed in two portions: one tablespoon (approximately 15 mL) in the morning or at lunch time, and another in the evening. The remaining 10 mL will be used as a substitute for usual dietary fats. This diet will be followed for approximately 13 weeks prior to bariatric surgery.

Treatment:

Other: conventional sunflower oil