NCT00728338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

July 31, 2008

Last Update Submit

August 7, 2008

Conditions

Hypertriglyceridemia

Keywords

docosahexenoic acid (DHA)dietary supplementn-3 polyunsaturated fatty acidcardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Plasma biomarkers of inflammation

    0, 45, and 90 days

Secondary Outcomes (4)

  • Granulocyte maturation

    0, 45, and 90 dyas

  • fasting and post-prandial serum lipids and lipoproteins

    0, 45, and 90 days

  • blood pressure and blood clotting

    0, 45, and 90 days

  • plasma biomarkers for diabetes

    0, 45, and 90 days

Study Arms (2)

1

EXPERIMENTAL

Martek Biosciences Corporation Neuromins Capsules 7.5 g DHA oil/day

Dietary Supplement: Docosahexenoic acid (DHA)

2

PLACEBO COMPARATOR

7.5 g/ day olive oil

Dietary Supplement: Olive oil

Interventions

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.

Also known as: Martek Biosciences Corporation, Neuromins Capsules
1
Olive oilDIETARY_SUPPLEMENT

7.5 g olive oil/day

2

Eligibility Criteria

Age39 Years - 66 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usda, Ars, Whnrc

Davis, California, 95616, United States

Location

Related Publications (4)

  • 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.

    PMID: 17684201RESULT

  • 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.

    PMID: 18156400RESULT

  • 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.

    PMID: 21999398DERIVED

  • 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.

    PMID: 21775114DERIVED

Related Links

MeSH Terms

Conditions

HypertriglyceridemiaCardiovascular Diseases

Interventions

Docosahexaenoic AcidsOlive Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Darshan S Kelley, PhD

    USDA, ARS, WHNRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

June 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

US(1)