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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DHA-O
Fish oil
Placebo
Sponsored by
DSM Nutritional Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biofortis Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

DHA-O

Fish oil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in TG levels

Secondary Outcome Measures

Change from baseline in lipid panel measures

Full Information

First Posted
November 27, 2012
Last Updated
April 24, 2014
Sponsor
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01737099
Brief Title
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
Acronym
DHA-O
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA-O
Arm Type
Experimental
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA-O
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in TG levels
Time Frame
week 14
Secondary Outcome Measure Information:
Title
Change from baseline in lipid panel measures
Time Frame
week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Maki, PhD
Organizational Affiliation
Biofortis Clinical Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biofortis Clinical Research
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25123060
Citation
Maki KC, Yurko-Mauro K, Dicklin MR, Schild AL, Geohas JG. A new, microalgal DHA- and EPA-containing oil lowers triacylglycerols in adults with mild-to-moderate hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):141-8. doi: 10.1016/j.plefa.2014.07.012. Epub 2014 Jul 22.
Results Reference
derived

Learn more about this trial

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

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