ObesityNAMICONCT07027033
Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity
A study testing acid-rich sunflower oil oleic acid and conventional sunflower oil in people with Obesity and Visceral Adipose Tissue, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obesity, Visceral Adipose Tissue, White Adipose Tissue Inflammation
- What is being tested?
- acid-rich sunflower oil oleic acid and conventional sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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):
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- 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).
Who cannot join
- • 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, France, 44093
Marie MD De Montrichard, PH, +332 40 08 30 22 ext. +33, marie.dabadie@chu-nantes.fr
Marie MD De Montrichard, PH
About this study
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, Visceral Adipose Tissue, White Adipose Tissue Inflammation, Subcutaneous Adipose Tissue
- Being tested
- acid-rich sunflower oil oleic acid, conventional sunflower oil
- Keywords
- obesity, visceral adipose tissue, adipocyte dysfunction, oleic acid, cholesterol esterification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acid-rich sunflower oil oleic acidOther
Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of sunflower oil rich in oleic acid
conventional sunflower oilOther
Nutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of conventional sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 weeks +/- 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start15 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- NAMICO is a physio-pathologic, monocentric, controlled , blinded, randomized trial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie De Montrichard, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027033
- Sponsor's protocol ID
- RC24_0626
- Other IDs
- 2024-A02770-47
- Acronym
- NAMICO
- Status last verified
- Jan 2026
- First submitted
- 16 May 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Oleic Acid Modulation of adIpose Cholesterol Metabolism in Patients Living With Obesity
- ClinicalTrials.gov ID
- NCT07027033
- Acronym / sponsor ID
- NAMICO / RC24_0626
- Conditions
- Obesity, Visceral Adipose Tissue, White Adipose Tissue Inflammation, Subcutaneous Adipose Tissue
- Keywords
- obesity, visceral adipose tissue, adipocyte dysfunction, oleic acid, cholesterol esterification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- NAMICO is a physio-pathologic, monocentric, controlled , blinded, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Oleic acid group | Experimental | Other: acid-rich sunflower oil oleic acidFemale 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. |
| Conventional oil group (control group) | Placebo comparator | Other: conventional sunflower oilFemale 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- • Individual who has given informed consent.
Key exclusion criteria (13 listed)
- • Modification of diabetes treatment within the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acid-rich sunflower oil oleic acidNutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of sunflower oil rich in oleic acid | Other | Oleic acid group |
| conventional sunflower oilNutritional intervention for 13 weeks ± 2 weeks, including 40 millilitres of conventional sunflower oil | Other | Conventional oil group (control group) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie De Montrichard, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acid-rich sunflower oil oleic acid and conventional sunflower oil in people with Obesity and Visceral Adipose Tissue, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie De Montrichard, PH (+332 40 08 30 22 ext. +33, marie.dabadie@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.