Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
Effect of Docosahexenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for Cardiovascular Disease in Hyperlipidemic Men
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular disease (CVD) and stroke are the leading causes of mortality in the United States, accounting for more than 38% of all deaths. Elevated total- and LDL- cholesterol, number of total and small dense LDL particles, triacylglycerols, and low HDL-C are established independent risk factors for the development of CVD. Additional novel blood lipid markers used as risk factors for CVD include, increased plasma concentration of remnant like particle-cholesterol (RLP-C), decreased ratio between plasma eicosapentaenoic acid (EPA) and arachidonic acd (AA), and decreased omega-3 index (sum of EPA and DHA as a percentage of total fatty acid content) of the red blood cells.
Diets rich in omega-3 fatty acids have been shown to be cardio-protective; these diets decreased inflammation, platelet aggregation, cardiac arrhythmias, triglycerides, number of total LDL and small dense LDL particles, and increased omega-3 index, endothelial relaxation and atherosclerotic plaque stability. Most of the earlier studies regarding the effects of long chain n-3 PUFA on blood lipids were conducted with fish oils which contain a mixture of EPA and DHA. Recently a number of studies have been conducted with EPA and DHA individually. Results from studies with individual fatty acids show that EPA and DHA have similar effects on some of the lipid parameters, but they are assimilated to a different concentration in tissues and have different effects on lipoprotein particle size, heart rate and blood pressure. The main purpose of this study is to examine the effects of DHA supplementation on the above three risk factors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Davis, California, United States, 95616
- USDA, ARS, WHNRC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- fasting serum triglyceride values of 150-400 mg/dL
- total cholesterol < 300 mg/dL
- LDL-cholesterol < 220 mg/dL
- BMI between 22 and 35 Kg/m2
Exclusion Criteria:
- anti-inflammatory medications including steroids
- antihypertensives
- non sulfonyl urea medications for diabetes mellitus
- drugs that alter serum triacylglycerols and HDL-C levels (i.e. fibrates)
- niacin supplements
- consumers of illegal substances
- consumers of more than 5 drinks of alcohol per week
- more than one fish meal per week
- dietary supplements of fish oil, flaxseed oil or vitamin C or E
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 1
Martek Biosciences Corporation Neuromins Capsules 7.5 g DHA oil/day
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The DHA group received 7.5 g/d DHA oil (DHA 3.0 g/d) which is produced in the microalga Crypthecodinium cohinii.
Other Names:
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PLACEBO_COMPARATOR: 2
7.5 g/ day olive oil
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7.5 g olive oil/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma biomarkers of inflammation
Time Frame: 0, 45, and 90 days
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0, 45, and 90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Granulocyte maturation
Time Frame: 0, 45, and 90 dyas
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0, 45, and 90 dyas
|
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fasting and post-prandial serum lipids and lipoproteins
Time Frame: 0, 45, and 90 days
|
0, 45, and 90 days
|
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blood pressure and blood clotting
Time Frame: 0, 45, and 90 days
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0, 45, and 90 days
|
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plasma biomarkers for diabetes
Time Frame: 0, 45, and 90 days
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0, 45, and 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Darshan S Kelley, PhD, USDA, ARS, WHNRC
Publications and helpful links
General Publications
- Kelley DS, Siegel D, Vemuri M, Mackey BE. Docosahexaenoic acid supplementation improves fasting and postprandial lipid profiles in hypertriglyceridemic men. Am J Clin Nutr. 2007 Aug;86(2):324-33. doi: 10.1093/ajcn/86.2.324.
- Kelley DS, Siegel D, Vemuri M, Chung GH, Mackey BE. Docosahexaenoic acid supplementation decreases remnant-like particle-cholesterol and increases the (n-3) index in hypertriglyceridemic men. J Nutr. 2008 Jan;138(1):30-5. doi: 10.1093/jn/138.1.30.
- Kelley DS, Adkins Y, Woodhouse LR, Swislocki A, Mackey BE, Siegel D. Docosahexaenoic acid supplementation improved lipocentric but not glucocentric markers of insulin sensitivity in hypertriglyceridemic men. Metab Syndr Relat Disord. 2012 Feb;10(1):32-8. doi: 10.1089/met.2011.0081. Epub 2011 Oct 14.
- Dawson K, Zhao L, Adkins Y, Vemuri M, Rodriguez RL, Gregg JP, Kelley DS, Hwang DH. Modulation of blood cell gene expression by DHA supplementation in hypertriglyceridemic men. J Nutr Biochem. 2012 Jun;23(6):616-21. doi: 10.1016/j.jnutbio.2011.03.004. Epub 2011 Jul 19.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHNRC002
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