Cardiovascular Risk FactorsNCT00527436
Fish Oil and Biomarkers of Cardiovascular Risk
A study testing fish oil in people with Cardiovascular Risk Factors, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2007
- Phase
- Interventional
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be healthy (as assessed by history and physical examination:
- Non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results.
- Women must be non-pregnant.
- Normal liver enzymes (ALT and AST).
Who cannot join
- Individuals with allergies to corn will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development.
Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk.
Read more
Study Population Healthy young (18-40 years of age) and older (50-79) men and women.
Major Inclusion \& Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.
Allocation to Groups Randomized, double-blinded, and placebo-controlled.
Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo
Read the detailed description
N/A - withdrawn
- Conditions
- Cardiovascular Risk Factors
- Being tested
- fish oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
Also called Omega-3 fatty acids
Fish oil pills will be taken daily for 12 weeks
PlaceboDietary supplement
Also called corn oil
Placebo (corn oil) will be taken daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Other | Fish oil pill Receives: Dietary Supplement: fish oil |
| Placebo | Placebo comparator | Placebo matched corn oil pill Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure will be measured using a cuff placed around the subject's upper arm as well as a small cuff placed on their finger.
Measured: every 2 weeks for a 12 week duration
Heart Rate
Two-inch square adhesive patches will be used to monitor your heart rate
Measured: every two weeks for 12 week duration
Arterial Pulse Wave Velocity
The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes.
Measured: every two weeks, for a 12 week duration
Aortic Blood Pressure
Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist.
Measured: every two weeks, for a 12 week duration
Brachial Artery Blood Flow
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after deflation of a blood pressure cuff that previously had been inflated tightly on the upper forearm for a period of 5 minutes
Measured: every two weeks, for a 12 week duration
Brachial Artery Blood flow: After Nitroglycerin (0.4mg)
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after placing a pill containing nitroglycerin (0.4mg) under the tongue.
Measured: every two weeks, for a 12 week duration
Microneurography
Two very fine, sterile nerve wires (micro-electrodes), thinner than a sewing needle, will be introduced through the skin into a nerve located just under the skin of the right leg. This procedure will measure nerve activity from the brain to the leg.
Measured: every two weeks, for a 12 week duration
Secondary outcomes (1)
Blood Withdrawal
An intravenous catheter will be inserted into veins near the elbow to collect blood for standard blood chemistry panel.
Measured: every two weeks, for a 12 week duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double Blind, Placebo Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Monahan, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527436
- Sponsor's protocol ID
- 25918
- Status last verified
- Apr 2019
- First submitted
- 6 Sep 2007
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil and Biomarkers of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00527436
- Acronym / sponsor ID
- 25918
- Conditions
- Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 10 Sep 2007 (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.
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development.
Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk.
Study Population Healthy young (18-40 years of age) and older (50-79) men and women.
Major Inclusion \& Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.
Allocation to Groups Randomized, double-blinded, and placebo-controlled.
Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo
Detailed description
N/A - withdrawn
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Other | Dietary Supplement: fish oilFish oil pill |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo matched corn oil pill |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results.
- Women must be non-pregnant.
- Normal liver enzymes (ALT and AST).
Key exclusion criteria (1 listed)
- Individuals with allergies to corn will be excluded.
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 |
|---|---|---|
| fish oilAlso: Omega-3 fatty acidsFish oil pills will be taken daily for 12 weeks | Dietary supplement | Dietary Supplement |
| PlaceboAlso: corn oilPlacebo (corn oil) will be taken daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Blood Pressure
Time frame: every 2 weeks for a 12 week duration
Blood pressure will be measured using a cuff placed around the subject's upper arm as well as a small cuff placed on their finger.
Heart Rate
Time frame: every two weeks for 12 week duration
Two-inch square adhesive patches will be used to monitor your heart rate
Arterial Pulse Wave Velocity
Time frame: every two weeks, for a 12 week duration
The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes.
Aortic Blood Pressure
Time frame: every two weeks, for a 12 week duration
Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist.
Brachial Artery Blood Flow
Time frame: every two weeks, for a 12 week duration
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after deflation of a blood pressure cuff that previously had been inflated tightly on the upper forearm for a period of 5 minutes
Brachial Artery Blood flow: After Nitroglycerin (0.4mg)
Time frame: every two weeks, for a 12 week duration
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after placing a pill containing nitroglycerin (0.4mg) under the tongue.
Microneurography
Time frame: every two weeks, for a 12 week duration
Two very fine, sterile nerve wires (micro-electrodes), thinner than a sewing needle, will be introduced through the skin into a nerve located just under the skin of the right leg. This procedure will measure nerve activity from the brain to the leg.
1 secondary outcome
Blood Withdrawal
Time frame: every two weeks, for a 12 week duration
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Kevin Monahan, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil in people with Cardiovascular Risk Factors, run by Milton S. Hershey Medical Center 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 4 inclusion and 1 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 10 Apr 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). 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?
Blood Pressure (time frame: every 2 weeks for a 12 week duration). The study lists 7 primary outcomes in all. 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 10 Apr 2019.