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

NCT07027033 | Recruiting

• 2 other identifiers: RC24_06262024-A02770-47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

obesity; visceral adipose tissue; adipocyte dysfunction; oleic acid; cholesterol esterification

Outcome Measures

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.

  13 weeks +/- 2 week

Study Arms (2)

Oleic acid group

EXPERIMENTAL

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.

Other: acid-rich sunflower oil oleic acid

Conventional oil group (control group)

PLACEBO COMPARATOR

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.

Other: conventional sunflower oil

Interventions

acid-rich sunflower oil oleic acid OTHER

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

Oleic acid group

conventional sunflower oil OTHER

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

Conventional oil group (control group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individual who has given informed consent.
• Female adult aged between 18 and 60 years (included).
• 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).
• 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).

You may not qualify if:

• 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).
• Participation in other clinical trials, except for non-interventional studies and research on surgical techniques or postoperative strategies.
• Type I, monogenic or secondary diabetes.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France, 44093, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie De Montrichard, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie De Montrichard, PH

CONTACT

+332 40 08 30 22; marie.dabadie@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Oil bottles will be numbered in accordance with a correspondence list generated electronically by the datamanager (blinding procedure for participant, investigator and their team).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: NAMICO is a physio-pathologic, monocentric, controlled , blinded, randomized trial

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 18, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)