Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
All Genders
NCT07287514

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

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-12-17

120

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 20 to 60 years
  • Insulin resistance with HOMA-IR greater than 2.6
  • Presence of 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 depending on cardiovascular risk), or elevated blood pressure (≥ 130/85 mmHg)
Not Eligible

You will not qualify if you...

  • Diagnosis of diabetes
  • Severe psychiatric illness
  • Malabsorption disorders or previous bariatric surgery
  • Pregnancy or lactation
  • Previous clinical cardiovascular disease
  • Regular use of medications affecting study outcomes, including lipid-lowering agents, insulin sensitizers, antihypertensives, anticoagulants, antiretroviral therapy, thyroid hormones, corticosteroids, immunosuppressants, or PUFA supplements
  • Fasting serum triglycerides ≥ 500 mg/dL or LDL cholesterol ≥ 190 mg/dL
  • Body mass index ≥ 35 kg/m²
  • Very high blood pressure
  • Any condition that may limit adherence to the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centro de Investigaciones Clínicas UC (CICUC) - Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile, 8330024

Actively Recruiting

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Research Team

L

Loni Berkowitz, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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