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

This study has been completed.
Information provided by (Responsible Party):
DSM Nutritional Products, Inc. Identifier:
First received: November 27, 2012
Last updated: April 24, 2014
Last verified: April 2014
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 Intervention
Hypertriglyceridemia Dietary Supplement: DHA-O Dietary Supplement: Fish oil Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by DSM Nutritional Products, Inc.:

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

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

Enrollment: 93
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA-O Dietary Supplement: DHA-O
Active Comparator: Fish oil Dietary Supplement: Fish oil
Placebo Comparator: Placebo Dietary Supplement: Placebo


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.
  More Information

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
Study First Received: November 27, 2012
Last Updated: April 24, 2014

Keywords provided by DSM Nutritional Products, Inc.:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on August 17, 2017