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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT01737099
First received: November 27, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in lipid panel measures [ Time Frame: week 14 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01737099

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

No publications provided

Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT01737099     History of Changes
Other Study ID Numbers: 2012-1048
Study First Received: November 27, 2012
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DSM Nutritional Products, Inc.:
omega-3
DHA
triglycerides
lipids
cardiovascular
hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 16, 2014