NCT02036307

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

January 13, 2014

Last Update Submit

February 28, 2017

Conditions

Hypertriglyceridemia

Keywords

Fish oilsTriglyceridesBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Fasting triglyceride level

    Fasting serum triglyceride levels

    4 weeks

Secondary Outcomes (1)

  • Seated blood pressure

    4 weeks

Study Arms (2)

DHA-enriched

EXPERIMENTAL

DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day)

Dietary Supplement: DHA-enriched

EPA-enriched

EXPERIMENTAL

EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day)

Dietary Supplement: EPA-enriched

Interventions

DHA-enrichedDIETARY_SUPPLEMENT

DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks

Also known as: Carlson Labs - Super DHA Gems
DHA-enriched
EPA-enrichedDIETARY_SUPPLEMENT

EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks

Also known as: Carlson Labs EPA gems
EPA-enriched

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dhananjay Vaidya

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

April 1, 2013

Primary Completion

May 1, 2013

Study Completion

January 1, 2015

Last Updated

March 1, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

We do not plan to share the individual patient data.

Locations

US(1)