Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia (DHA-O)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01737099
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Brief Summary:
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dietary Supplement: DHA-O Dietary Supplement: Fish oil Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: DHA-O Dietary Supplement: DHA-O
Active Comparator: Fish oil Dietary Supplement: Fish oil
Placebo Comparator: Placebo Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Change from baseline in TG levels [ Time Frame: week 14 ]

Secondary Outcome Measures :
  1. Change from baseline in lipid panel measures [ Time Frame: week 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ages 18-79
  • fasting TG levels, 150-499 mg/dL
  • baseline DHA intake <200mg/d
  • active and in good health

Exclusion Criteria:

  • recent diagnosis of CHD or history of revascularization within 6mos of study
  • use of lipid altering medications (other than stable statins)
  • use of anticoagulants
  • use of omega-3 products within 4 weeks of screening
  • serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening
  • lipid altering foods or supplements
  • women who are pregnant or of childbearing potential not using adequate birth control
  • current use or history of drug or alcohol abuse
  • inability to swallow capsules

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01737099

United States, Illinois
Biofortis Clinical Research
Addison, Illinois, United States, 60101
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Principal Investigator: Kevin Maki, PhD Biofortis Clinical Research, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: DSM Nutritional Products, Inc. Identifier: NCT01737099     History of Changes
Other Study ID Numbers: 2012-1048
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by DSM Nutritional Products, Inc.:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases