HypertriglyceridemiaPhase 2SOMANCT02036307
Supplementation With Omega-3: Mechanism of Action
A Phase 2 study testing DHA-enriched and EPA-enriched in people with Hypertriglyceridemia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- DHA-enriched and EPA-enriched
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertriglyceridemia
- Being tested
- DHA-enriched, EPA-enriched
- Keywords
- Fish oils, Triglycerides, Blood pressure
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-enrichedDietary supplement
Also called Carlson Labs - Super DHA Gems
DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks
EPA-enrichedDietary supplement
Also called Carlson Labs EPA gems
EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| DHA-enriched | Experimental | DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day) Receives: Dietary Supplement: DHA-enriched |
| EPA-enriched | Experimental | EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day) Receives: Dietary Supplement: EPA-enriched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting triglyceride level
Fasting serum triglyceride levels
Measured: 4 weeks
Secondary outcomes (1)
Seated blood pressure
Seated blood pressure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionJan 2015
Why it stopped: This study was suspended because there is no more funds to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhananjay Vaidya, Johns Hopkins University
- Investigators
- Dhananjay Vaidya, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036307
- Sponsor's protocol ID
- NA_00076636
- Acronym
- SOMA
- Status last verified
- Feb 2017
- First submitted
- 13 Jan 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We do not plan to share the individual patient data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Omega-3: Mechanism of Action
- ClinicalTrials.gov ID
- NCT02036307
- Acronym / sponsor ID
- SOMA / NA_00076636
- Conditions
- Hypertriglyceridemia
- Keywords
- Fish oils, Triglycerides, Blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was suspended because there is no more funds to complete the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-enriched | Experimental | Dietary Supplement: DHA-enrichedDHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day) |
| EPA-enriched | Experimental | Dietary Supplement: EPA-enrichedEPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA-enrichedAlso: Carlson Labs - Super DHA GemsDHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks | Dietary supplement | DHA-enriched |
| EPA-enrichedAlso: Carlson Labs EPA gemsEPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks | Dietary supplement | EPA-enriched |
Primary outcome
Fasting triglyceride level
Time frame: 4 weeks
Fasting serum triglyceride levels
1 secondary outcome
Seated blood pressure
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: This study was suspended because there is no more funds to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Individual participant dataSharing planned: No. We do not plan to share the individual patient data.
Related trials for Hypertriglyceridemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhananjay Vaidya principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DHA-enriched and EPA-enriched in people with Hypertriglyceridemia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was suspended because there is no more funds to complete the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting triglyceride level (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.