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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02042274
Acronym
FOHS
Enrollment
12
Registered
2014-01-22
Start date
2012-10-31
Completion date
2015-02-28
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

Fish oil, EPA, DHA, fatty acids, genetic variation, gene expression

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.

Interventions

DIETARY_SUPPLEMENTFish oil supplement

Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.

Sponsors

University of Guelph
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood TriglycerideBaseline, 3 months, 5 monthsBlood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

Secondary

MeasureTime frameDescription
Blood GlucoseBaseline, 3 months, 5 monthsBlood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

Countries

Canada

Participant flow

Participants by arm

ArmCount
Fish Oil
Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
12
Total12

Baseline characteristics

CharacteristicFish Oil
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
Region of Enrollment
Canada
12 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
12 Participants
Triglycerides0.9 mmol/L
STANDARD_DEVIATION 0.3

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

Blood Triglyceride

Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

Time frame: Baseline, 3 months, 5 months

Population: Healthy adults, ranging in age from 18-65 years.

ArmMeasureGroupValue (MEAN)Dispersion
Fish Oil SupplementBlood TriglycerideBaseline0.9 mmol/LStandard Deviation 0.3
Fish Oil SupplementBlood Triglyceride3 Months0.8 mmol/LStandard Deviation 0.3
Fish Oil SupplementBlood Triglyceride5 months0.9 mmol/LStandard Deviation 0.5
Secondary

Blood Glucose

Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.

Time frame: Baseline, 3 months, 5 months

ArmMeasureGroupValue (MEAN)Dispersion
Fish Oil SupplementBlood GlucoseBaseline4.4 mmol/LStandard Deviation 1.4
Fish Oil SupplementBlood Glucose3 Months3.9 mmol/LStandard Deviation 1.3
Fish Oil SupplementBlood Glucose5 months4.2 mmol/LStandard Deviation 1.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026