Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
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Purpose
The purpose of this study is to determine the effects of supplementing diets of hyperlipidemic men with DHA (docosahexenoic acid) on risk factors for cardiovascular disease. We hypothesize that supplementing diets of hyperlipidemic men with DHA will decrease the plasma concentrations of CRP (C-reactive protein), inflammatory cytokines, and soluble adhesion molecules. We further hypothesize that DHA supplementation will decrease serum triglyceride concentrations and increase HDL concentration.
| Condition | Intervention |
|---|---|
|
Hypertriglyceridemia |
Dietary Supplement: Docosahexenoic acid (DHA) Dietary Supplement: Olive oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Docosahexenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for Cardiovascular Disease in Hyperlipidemic Men |
- Plasma biomarkers of inflammation [ Time Frame: 0, 45, and 90 days ] [ Designated as safety issue: No ]
- Granulocyte maturation [ Time Frame: 0, 45, and 90 dyas ] [ Designated as safety issue: No ]
- fasting and post-prandial serum lipids and lipoproteins [ Time Frame: 0, 45, and 90 days ] [ Designated as safety issue: No ]
- blood pressure and blood clotting [ Time Frame: 0, 45, and 90 days ] [ Designated as safety issue: No ]
- plasma biomarkers for diabetes [ Time Frame: 0, 45, and 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | June 2003 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Martek Biosciences Corporation Neuromins Capsules 7.5 g DHA oil/day
|
Dietary Supplement: Docosahexenoic acid (DHA)
The DHA group received 7.5 g/d DHA oil (DHA 3.0 g/d) which is produced in the microalga Crypthecodinium cohinii.
Other Name: Martek Biosciences Corporation, Neuromins Capsules
|
|
Placebo Comparator: 2
7.5 g/ day olive oil
|
Dietary Supplement: Olive oil
7.5 g olive oil/day
|
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.
Eligibility| Ages Eligible for Study: | 39 Years to 66 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Usda, Ars, Whnrc | |
| Davis, California, United States, 95616 | |
| Principal Investigator: | Darshan S Kelley, PhD | USDA, ARS, WHNRC |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Darshan S. Kelley, Ph.D., USDA, ARS, WHNRC |
| ClinicalTrials.gov Identifier: | NCT00728338 History of Changes |
| Other Study ID Numbers: | WHNRC002 |
| Study First Received: | July 31, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by USDA, Western Human Nutrition Research Center:
|
docosahexenoic acid (DHA) dietary supplement n-3 polyunsaturated fatty acid cardiovascular disease |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertriglyceridemia Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013