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Completed

NCT Number: NCT00728338

Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides

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.

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Key information

Age range

39 year–66 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Usda, Ars, Whnrc

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docosahexenoic acid (DHA)

Dietary Supplement

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: Martek Biosciences Corporation, Neuromins Capsules

Olive Oil

Dietary Supplement

7.5 g olive oil/day

Primary outcomes

  1. Plasma biomarkers of inflammation

    Time frame: 0, 45, and 90 days

Secondary outcomes

  1. Granulocyte maturation

    Time frame: 0, 45, and 90 dyas

  2. fasting and post-prandial serum lipids and lipoproteins

    Time frame: 0, 45, and 90 days

  3. blood pressure and blood clotting

    Time frame: 0, 45, and 90 days

  4. plasma biomarkers for diabetes

    Time frame: 0, 45, and 90 days

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • VA Northern California Health Care System
  • dsm-firmenich Switzerland AG

Registry information

Official study title

Effect of Docosahexenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for Cardiovascular Disease in Hyperlipidemic Men

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 5, 2008
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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