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NCT Number: NCT07027033

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Subcutaneous Adipose Tissue Visceral Adipose Tissue White Adipose Tissue Inflammation

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, France, 44093

Location status: Recruiting

Location contact

Marie MD De Montrichard, PH

CONTACT

[email protected]

+332 40 08 30 22 ext. +33

Marie MD De Montrichard, PH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acid-rich sunflower oil oleic acid

Other

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

conventional sunflower oil

Other

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

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.

    Time frame: 13 weeks +/- 2 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie De Montrichard, PH

CONTACT

[email protected]

+332 40 08 30 22 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: NAMICO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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