Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
Study NCT ID:
NCT03378232
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2017-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids
Sponsor:
University of Guelph
Organization:
Study Overview
Official Title:
EPA and DHA Regulation of Blood Triglycerides, Resting Metabolic Rate and Blood Markers of Cardiometabolic Health.
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TGIF
Brief Summary:
Omega 3 fatty acids have been shown to provide a number of cardiometabolic benefits in both healthy and at risk populations. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. Furthermore, a number of cardiovascular effects (i.e. reduced blood pressure, reduced coagulation) have been found to result from omega-3 consumption, as well as influencing energy expenditure (i.e. resting metabolic rate). The goal of this study is to examine the cardiometabolic and cardiovascular effects that result from long-term consumption of omega-3 fatty acids.
Detailed Description:
Cardiovascular disease (CVD) and type 2 diabetes (T2D) are major contributors to healthcare costs in Canada. A cluster of cardiometabolic risk factors including insulin resistance, dyslipidemia, hypertension, and abdominal obesity increases the risk of developing the aforementioned diseases. While drugs can help to treat or slow the development of cardiometabolic problems, they are not always effective and in some instances can have adverse effects on a patient's health. In comparison, changing, modifying or improving dietary habits is now recognized as a safe and effective way to help reduce the risk of developing CVD, as well as treat CVD and T2D. The consumption of omega-3 fatty acids (FAs) is highly recommended due to their known benefits for health and development; however, considerable variability exists in the literature regarding the benefits of omega-3 FAs. This variability stems from differences in study design; differing in dosage, duration of supplementation, population studied, sample size, as well as the amounts of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) used in supplements. The current study will investigate the effects of EPA and DHA on markers of cardiometabolic and cardiovascular health in young adults.
To assess the effectiveness of EPA and DHA on markers of cardiometabolic health, including
1. blood lipids, such as triglycerides, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels
2. markers of inflammation, such as high-sensitivity C-reactive protein (hs-CRP) and other circulating cytokines
3. whole-body glucose and insulin levels
4. resting metabolic rate
5. blood pressure and muscle sympathetic nerve activity
To assess the effectiveness of EPA and DHA on markers of cardiometabolic health, including
1. blood lipids, such as triglycerides, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels
2. markers of inflammation, such as high-sensitivity C-reactive protein (hs-CRP) and other circulating cytokines
3. whole-body glucose and insulin levels
4. resting metabolic rate
5. blood pressure and muscle sympathetic nerve activity
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: