Supplementation With Omega-3: Mechanism of Action (SOMA)
Primary Purpose
Hypertriglyceridemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHA-enriched
EPA-enriched
Sponsored by
About this trial
This is an interventional prevention trial for Hypertriglyceridemia focused on measuring Fish oils, Triglycerides, Blood pressure
Eligibility Criteria
Inclusion Criteria:
- Healthy adults 20-75 years of age.
- Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.
Exclusion Criteria:
- Current user of fish oil supplements
- Current user of statins
- Allergy to fish or seafood products
- Diagnosed/treated diabetes mellitus
- Using aspirin or NSAIDS or other "blood-thinning medication"
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DHA-enriched
EPA-enriched
Arm Description
DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day)
EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day)
Outcomes
Primary Outcome Measures
Fasting triglyceride level
Fasting serum triglyceride levels
Secondary Outcome Measures
Seated blood pressure
Seated blood pressure
Full Information
NCT ID
NCT02036307
First Posted
January 13, 2014
Last Updated
February 28, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02036307
Brief Title
Supplementation With Omega-3: Mechanism of Action
Acronym
SOMA
Official Title
Supplementation With Omega-3: Mechanism of Action
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was suspended because there is no more funds to complete the study.
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.
Detailed Description
Observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. However, the mechanisms of action of fish oils are not well understood. Specifically, the effects of different compositions in terms of the ratio of the fatty acids EPA and DHA are not known. We are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high EPA/DHA ratio, high DHA/EPA ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . We will also bank blood and urine for future mechanistic studies. This pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
Fish oils, Triglycerides, Blood pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHA-enriched
Arm Type
Experimental
Arm Description
DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day)
Arm Title
EPA-enriched
Arm Type
Experimental
Arm Description
EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA-enriched
Other Intervention Name(s)
Carlson Labs - Super DHA Gems
Intervention Description
DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA-enriched
Other Intervention Name(s)
Carlson Labs EPA gems
Intervention Description
EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks
Primary Outcome Measure Information:
Title
Fasting triglyceride level
Description
Fasting serum triglyceride levels
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Seated blood pressure
Description
Seated blood pressure
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults 20-75 years of age.
Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.
Exclusion Criteria:
Current user of fish oil supplements
Current user of statins
Allergy to fish or seafood products
Diagnosed/treated diabetes mellitus
Using aspirin or NSAIDS or other "blood-thinning medication"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhananjay Vaidya
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share the individual patient data.
Learn more about this trial
Supplementation With Omega-3: Mechanism of Action
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