Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults

Summary

The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.

Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:

1. Improve how well the body produces insulin and responds to it,
2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.

To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.

When included in this study, participants will:

A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.

Conditions

• Type 2 Diabetes
• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
• Prediabetes / Type 2 Diabetes
• Obesity & Overweight
• Obesity and Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

Fish Oil

Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)

DIETARY_SUPPLEMENT

Fish Oil

Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)

DIETARY_SUPPLEMENT

Corn oil control

Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)

Sponsors & Collaborators

• Diabetes Canada

  collaborator OTHER

• May Faraj, PDt, PhD

  lead OTHER

Principal Investigators

• May Faraj, P.Dt., Ph.D. · Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Canada

Study Locations