Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids

Cardiovascular Disease Clinical Trial

— TGIF  

Official title:

EPA and DHA Regulation of Blood Triglycerides, Resting Metabolic Rate and Blood Markers of Cardiometabolic Health.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378232
• Other study ID #: The Goodness In Fish Oil
• Status: Completed
• Phase: N/A
• First received: December 12, 2017
• Last updated: February 16, 2018
• Start date: January 5, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: February 2018
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 30, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18-30 years

• Healthy

Exclusion Criteria:

• Younger than 18 years

• Older than 30 years

• Allergic to fish and/or shellfish or gelatin

• High consumption of omega-3 fats (either fatty fish or dietary supplements)

• Chronic or communicable diseases

• Anticipated change in lifestyle (moving to a new house, starting a new fitness routine).

• Discomfort giving blood

• Use of lipid-controlling medication, including cholesterol lowering drugs (statins), fatty acid/triglyceride altering (fibrates) or any other drug known to have lipid altering effects, such as ezetimibe, colesevelam, torcetrapib, avasimibe, and implitapide

• Chronic use of anti-inflammatory medications

• Pregnant, or is planning to become pregnant during the study

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Placebo Olive Oil
Each participant was instructed to consume the dietary supplement on a daily basis for 12 weeks.
• High EPA Supplement
Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.
• High DHA Supplement
Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Ontario Ministry of Agriculture, Food and Rural Affairs

References & Publications (5)

Klingel SL, Roke K, Hidalgo B, Aslibekyan S, Straka RJ, An P, Province MA, Hopkins PN, Arnett DK, Ordovas JM, Lai CQ, Mutch DM. Sex Differences in Blood HDL-c, the Total Cholesterol/HDL-c Ratio, and Palmitoleic Acid are Not Associated with Variants in Common Candidate Genes. Lipids. 2017 Dec;52(12):969-980. doi: 10.1007/s11745-017-4307-5. Epub 2017 Oct 27. — View Citation

Merino DM, Ma DW, Mutch DM. Genetic variation in lipid desaturases and its impact on the development of human disease. Lipids Health Dis. 2010 Jun 18;9:63. doi: 10.1186/1476-511X-9-63. Review. — View Citation

Miller PE, Van Elswyk M, Alexander DD. Long-chain omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and blood pressure: a meta-analysis of randomized controlled trials. Am J Hypertens. 2014 Jul;27(7):885-96. doi: 10.1093/ajh/hpu024. Epub 2014 Mar 6. — View Citation

Roke K, Jannas-Vela S, Spriet LL, Mutch DM. FADS2 genotype influences whole-body resting fat oxidation in young adult men. Appl Physiol Nutr Metab. 2016 Jul;41(7):791-4. doi: 10.1139/apnm-2016-0043. Epub 2016 Mar 16. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 Index	Omega-3 Index, as determined by measuring omega-3 fats in red blood cells using gas chromatography	CHANGE from Baseline at 12 weeks
Secondary	Triglycerides	Fasted serum triglycerides (mmol/L)	CHANGE from Baseline at 12 weeks
Secondary	High-sensitivity C-Reactive Protein (hs-CRP)	Blood hs-CRP levels	CHANGE from Baseline at 12 weeks
Secondary	Energy Expenditure	Resting Metabolic Rate	CHANGE from Baseline at 12 weeks
Secondary	Blood Pressure	Both systolic and diastolic blood pressure will be assessed	CHANGE from Baseline at 12 weeks
Secondary	Muscle sympathetic nerve activity (MSNA)	Fibular nerve microneurography	Change from Baseline at 12 weeks