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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728338
• Other study ID #: WHNRC002
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: August 7, 2008
• Start date: June 2003
• Est. completion date: November 2005

Study information

• Verified date: August 2008
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 39 Years to 66 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertriglyceridemia

Intervention

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.
• Olive oil
7.5 g olive oil/day

Locations

Country	Name	City	State
United States	Usda, Ars, Whnrc	Davis	California

Sponsors (3)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	DSM Nutritional Products, Inc., VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma biomarkers of inflammation		0, 45, and 90 days	No
Secondary	Granulocyte maturation		0, 45, and 90 dyas	No
Secondary	fasting and post-prandial serum lipids and lipoproteins		0, 45, and 90 days	No
Secondary	blood pressure and blood clotting		0, 45, and 90 days	No
Secondary	plasma biomarkers for diabetes		0, 45, and 90 days	No

External Links

•   USDA, ARS, WHNRC