About this trial
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.
Eligibility criteria
Qualifiers
With a body mass index (BMI >25-40 kg/m2)
Having confirmed menopausal status (FSH ≥ 30 U/l)
Non-smokers (tobacco) or have quitted for over a year
Low-moderate alcohol consumption: <7 alcoholic servings/ week
Disqualifiers
Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)
Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)
Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
Diabetes or HbA1c ≥ 6.5%
Trial design
Treatments tested in this trial
- Fish Oil
- Fish Oil
- Corn oil control
Treatment groups
Sponsors and collaborators
May Faraj, PDt, PhD
Lead sponsor
Institut de Recherches Cliniques de Montreal
Sponsor institution
Diabetes Canada
Collaborator