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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00728338
Enrollment
40
Registered
2008-08-05
Start date
2003-06-30
Completion date
2005-11-30
Last updated
2008-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

docosahexenoic acid (DHA), dietary supplement, n-3 polyunsaturated fatty acid, cardiovascular disease

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTDocosahexenoic 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.

DIETARY_SUPPLEMENTOlive oil

7.5 g olive oil/day

Sponsors

VA Northern California Health Care System
CollaboratorFED
DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
USDA, Western Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
39 Years to 66 Years
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

Design outcomes

Primary

MeasureTime frame
Plasma biomarkers of inflammation0, 45, and 90 days

Secondary

MeasureTime frame
Granulocyte maturation0, 45, and 90 dyas
fasting and post-prandial serum lipids and lipoproteins0, 45, and 90 days
blood pressure and blood clotting0, 45, and 90 days
plasma biomarkers for diabetes0, 45, and 90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026