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

Sponsor
Pontificia Universidad Catolica de Chile
Study ID
NCT07287514
Status
Recruiting
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Conditions

  • Insulin Resistance
  • Metabolic Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Linoleic Acid-Rich Oil — DIETARY_SUPPLEMENT
    Participants in the experimental group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The oil is characterized by a high content of omega-6 polyunsaturated fatty acids, primarily linoleic acid (\~60%). To facilitate adherence and appropriate use, participants will receive a recipe booklet encouraging the use of the oil in cold or minimally cooked preparations, or as a topping over foods. They will be instructed to avoid prolonged heating and to store the oil protected from light and at room temperature. The supplement will be provided in identical coded bottles to maintain single-blind conditions. Participants will be asked to maintain their usual diet and lifestyle throughout the intervention.
  • Blend Oil — DIETARY_SUPPLEMENT
    Participants in the control group will receive a daily supplement of a blend oil at a dose of 0.4 mL per kilogram of body weight per day, taken orally for 8 weeks. The blend was formulated to contain approximately equal proportions of saturated, monounsaturated, and polyunsaturated fatty acids, with less than half the linoleic acid content of the LA-rich oil. Participants will receive a recipe booklet promoting the use of the oil in cold dishes or lightly cooked preparations, or as a dressing or drizzle over meals. They will also be instructed on proper storage away from heat and direct light. The supplement will be supplied in identical coded bottles to ensure blinding. Participants will maintain their usual diet and lifestyle during the intervention.

Study Details

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.

Key Dates

First listed
Dec 17, 2025
Start date
May 13, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Linoleic Acid-Rich Oil
    Participants in this group will receive a daily supplement of a linoleic acid (LA)-rich oil at a dose of 0.4 mL per kilogram of body weight per day for 8 weeks.
  • Active Comparator: Blend Oil
    Participants in this group will receive a daily supplement of a blend oil at 0.4 mL per kilogram of body weight per day for 8 weeks.

Primary Outcome Measure

Change in insulin resistance (HOMA-IR) [ Time Frame: Baseline and 8 weeks after the start of the intervention. ]

Central Contacts

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