Linoleic acid–rich oil versus blended oil for adults with insulin resistance
Role of Linoleic Acid in Cardiometabolic Health Beyond Its Lipid-lowering Effects, and Its Dietary and Pathophysiological Implications
This trial will test whether taking a linoleic acid–rich oil daily for 8 weeks improves insulin resistance in adults who already have insulin resistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT07287514 on ClinicalTrials.gov |
What this trial studies
In a single-blind, randomized, parallel-group intervention, adults with insulin resistance will be assigned to take either a linoleic acid–rich oil supplement or a control blended oil each day for 8 weeks while keeping their usual diet and lifestyle. The main outcome is change in insulin resistance measured by HOMA-IR, with secondary outcomes including fasting glucose and insulin, lipid profile, inflammatory and oxidative stress markers, and body composition. Participants are adults aged 20–60 with HOMA-IR > 2.6 and at least one cardiometabolic risk factor, and people with diabetes, prior cardiovascular disease, or on certain medications are excluded. The trial is conducted at a single clinical research center and aims to provide controlled randomized data on the metabolic effects of increasing dietary linoleic acid.
Who should consider this trial
Good fit: Adults aged 20–60 with documented insulin resistance (HOMA-IR > 2.6) and at least one cardiometabolic risk factor who are not diabetic and are not taking medications that affect lipids or insulin sensitivity are ideal candidates.
Not a fit: People with diagnosed diabetes, prior clinical cardiovascular disease, recent bariatric surgery, pregnancy or lactation, malabsorption disorders, or regular use of excluded medications or PUFA supplements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this intervention could offer a simple dietary supplement approach to improve insulin sensitivity and related metabolic markers in people with insulin resistance.
How similar studies have performed: Observational studies and meta-analyses have linked higher linoleic acid intake to better lipid profiles and lower diabetes risk, but well-controlled randomized trials testing metabolic outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 20 to 60 years. * Insulin resistance (HOMA-IR \> 2.6). * At least one cardiometabolic risk factor: abdominal obesity (waist circumference \> 90 cm in men or \> 80 cm in women); low HDL-cholesterol (\< 40 mg/dL in men or \< 50 mg/dL in women); elevated LDL-cholesterol (\> 70 / 100 / 130 mg/dL, according to estimated cardiovascular risk); or elevated blood pressure (≥ 130/85 mmHg). Exclusion Criteria: * Diabetes diagnosis. * Severe psychiatric illness. * Malabsorption disorders or previous bariatric surgery. * Pregnancy or lactation. * Previous clinical cardiovascular disease. * Regular use of medications that could influence study outcomes, including: lipid-lowering agents insulin sensitizers antihypertensive drugs anticoagulants antiretroviral therapy thyroid hormones oral corticosteroids immunosuppressants polyunsaturated fatty acid (PUFA) supplements. * Fasting serum triglycerides ≥ 500 mg/dL or LDL-cholesterol ≥ 190 mg/dL. * Body mass index (BMI) ≥ 35 kg/m². * Very high blood pressure. * Any additional condition that may limit adherence to the study.
Where this trial is running
Santiago, Santiago Metropolitan
- Centro de Investigaciones Clínicas UC (CICUC) - Pontificia Universidad Católica de Chile — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Principal investigator: Loni Berkowitz, PhD — Pontificia Universidad Catolica de Chile
- Study coordinator: Loni Berkowitz, PhD
- Email: lberkowi@uc.cl
- Phone: 23543862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.