NCT07287514 Metabolic Effects of Linoleic Acid-Rich Oil Compared to a Blend Oil in Adults With Insulin Resistance
| NCT ID | NCT07287514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Insulin Resistance |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Linoleic acid (LA), the predominant omega-6 polyunsaturated fatty acid in human diets, has been associated with improved lipid metabolism and insulin sensitivity compared with saturated fats. However, its role in metabolic health remains debated due to the limited number of well-controlled intervention studies. This randomized controlled trial aims to evaluate the metabolic effects of an LA-rich oil compared with a blended oil in adults with insulin resistance. Participants will be randomly assigned to receive either a daily supplement of LA-rich oil or a control blend oil for 8 weeks, while maintaining their usual diet and lifestyle. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include changes in fasting glucose, insulin, lipid profile, inflammatory and oxidative stress markers, and body composition. The study is designed as a single-blind, parallel-group intervention conducted at the Pontifical Catholic University of Chile. The results are expected to clarify the effects of increased dietary linoleic acid intake on insulin sensitivity and metabolic risk factors, contributing to the ongoing debate about the role of omega-6 fatty acids in cardiometabolic health.
Eligibility 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.
Contact & Investigator
Loni Berkowitz, PhD
PRINCIPAL INVESTIGATOR
Pontificia Universidad Catolica de Chile
Frequently Asked Questions
Who can join the NCT07287514 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07287514 currently recruiting?
Yes, NCT07287514 is actively recruiting participants. Contact the research team at lberkowi@uc.cl for enrollment information.
Where is the NCT07287514 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07287514 clinical trial?
NCT07287514 is sponsored by Pontificia Universidad Catolica de Chile. The principal investigator is Loni Berkowitz, PhD at Pontificia Universidad Catolica de Chile. The trial plans to enroll 120 participants.