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Metabolic Effects of Linoleic Acid-Rich Oil Compared to a Blend Oil in Adults With Insulin Resistance

Sponsored by Pontificia Universidad Catolica de Chile

About this trial

Last updated 5 months ago

Study ID

230330018

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

20 to 60 Years
All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

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.