Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docosahexenoic acid (DHA)
Olive oil
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring docosahexenoic acid (DHA), dietary supplement, n-3 polyunsaturated fatty acid, cardiovascular disease
Eligibility Criteria
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
Sites / Locations
- Usda, Ars, Whnrc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Martek Biosciences Corporation Neuromins Capsules 7.5 g DHA oil/day
7.5 g/ day olive oil
Outcomes
Primary Outcome Measures
Plasma biomarkers of inflammation
Secondary Outcome Measures
Granulocyte maturation
fasting and post-prandial serum lipids and lipoproteins
blood pressure and blood clotting
plasma biomarkers for diabetes
Full Information
NCT ID
NCT00728338
First Posted
July 31, 2008
Last Updated
August 7, 2008
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
VA Northern California Health Care System, DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00728338
Brief Title
Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
Official Title
Effect of Docosahexenoic Acid (22:6n-3, DHA) Supplementation on Risk Factors for Cardiovascular Disease in Hyperlipidemic Men
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
VA Northern California Health Care System, DSM Nutritional Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
docosahexenoic acid (DHA), dietary supplement, n-3 polyunsaturated fatty acid, cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Martek Biosciences Corporation Neuromins Capsules 7.5 g DHA oil/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
7.5 g/ day olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexenoic acid (DHA)
Other Intervention Name(s)
Martek Biosciences Corporation, Neuromins Capsules
Intervention Description
The DHA group received 7.5 g/d DHA oil (DHA 3.0 g/d) which is produced in the microalga Crypthecodinium cohinii.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
7.5 g olive oil/day
Primary Outcome Measure Information:
Title
Plasma biomarkers of inflammation
Time Frame
0, 45, and 90 days
Secondary Outcome Measure Information:
Title
Granulocyte maturation
Time Frame
0, 45, and 90 dyas
Title
fasting and post-prandial serum lipids and lipoproteins
Time Frame
0, 45, and 90 days
Title
blood pressure and blood clotting
Time Frame
0, 45, and 90 days
Title
plasma biomarkers for diabetes
Time Frame
0, 45, and 90 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darshan S Kelley, PhD
Organizational Affiliation
USDA, ARS, WHNRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Usda, Ars, Whnrc
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17684201
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. doi: 10.1093/ajcn/86.2.324.
Results Reference
result
PubMed Identifier
18156400
Citation
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.
Results Reference
result
PubMed Identifier
21999398
Citation
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.
Results Reference
derived
PubMed Identifier
21775114
Citation
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.
Results Reference
derived
Links:
URL
http://www.ars.usda.gov/main/site_main.htm?modecode=53062500
Description
USDA, ARS, WHNRC
Learn more about this trial
Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
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