Clinical trial NCT02042274: Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health
Official title: Omega-3 Fatty Acids and Genes Interact to Influence Cardiometabolic Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Fish oil
EPA
DHA
fatty acids
genetic variation
gene expression
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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).
2. 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).
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Triglyceride
timeFrame: Baseline, 3 months, 5 months
Secondary outcomes:
measure: Blood Glucose
timeFrame: Baseline, 3 months, 5 months
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph - Human Nutraceutical Research Unit
state: Ontario
Study officials:
affiliation: University of Guelph
name: David M Mutch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.