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.
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
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%
Parallel
Fish Oil
Dietary supplementFour softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)
Fish Oil
Dietary supplementFour softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)
Corn oil control
Dietary supplementFour softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)
Change from baseline to 12 weeks in the disposition index
Disposition index calculated as first phase glucose-induced insulin secretion multiplied by insulin sensitivity measured during the Botnia clamp \[(ng C-peptide/mL)\*(mg dextrose/kg/min)/(µU insulin/mL)\]
Change from baseline to 12 weeks in glucose-induced insulin secretion
Glucose-induced insulin secretion measured by the Botnia clamp (ng C-peptide/mL)
Change from baseline to 12 weeks in insulin sensitivity
Insulin sensitivity measured by the Botnia clamp (mg dextrose/kg/min)/(uU insulin/mL)
Change from baseline to 12 weeks in the oral disposition index
Oral disposition index calculated as insulin secretion index (0-30 min) multiplied by insulin sensitivity index measured during an oral glucose tolerance test (arbitrary unit)
Change from baseline to 12 weeks in low-density lipoprotein (LDL) size
LDL size measured by Quantimetrix Lipoprint System (Å)
Change from baseline to 12 weeks in LDL-induced WAT inflammation
LDL-induced WAT inflammation measured as WAT secretion of a panel of pro- and anti-inflammatory mediators/markers (e.g. IL-1β, MCP1, IL10) by multiplex. This will be measured after the incubation of participant WAT biopsies without or with their own LDL ex vivo.
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May Faraj, PDt, PhD
Lead sponsor
Institut de Recherches Cliniques de Montreal
Sponsor institution
Diabetes Canada
Collaborator
Health Canada
Collaborator
