Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health

Study Overview
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Brief Summary
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Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. However, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. The goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.

Detailed Description
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The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches: The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc). The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods). The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.

Official Title
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Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: Fish oil supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18-25 years old male good general health Exclusion Criteria: currently taking a fish oil supplement currently taking an omega-3 supplement currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA) not able to maintain a consistent lifestyle routine throughout the study duration have an allergy which would prevent them from taking a fish oil pill schedule conflict with study visits overweight or obese

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil supplement<br>Fish oil supplements providing up to 3g per day of EPA and DHA | Dietary Supplement: Fish oil supplement<br>* Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.<br>* Other names: Ocean Nutrition MEG-3 supplements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Triglyceride | Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Baseline, 3 months, 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose | Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period. | Baseline, 3 months, 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPA, Fish oil, DHA, fatty acids, genetic variation, gene expression