Sudden Cardiac DeathNKNCT01038440
Time and Dose Evaluation of Stearidonic Acid (SDA) to Eicosapentaenoic Acid (EPA) in Red Blood Cells
A study testing Safflower Oil, EPA and SDA in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Solae, LLC.
Trial summary
The purpose of this study is to assess the relationships between dose and time of consumption of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell (RBC) membranes in men and women. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death, Sudden Cardiac Arrest, Cardiovascular Disease
- What is being tested?
- Safflower Oil, EPA and SDA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2010
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 21 to 65 years of age, inclusive.
- Body mass index (BMI) 18.00-39.99 kg/m2, at visit 1 (week -2).
- Subject is willing to avoid alcohol consumption for 24 hr prior to every clinic visit.
- The subject has no plans to change smoking habits during the study period.
- Subject is willing to maintain a stable body weight, current activity level, and dietary habits except for use of the study products as directed.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- 1. Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
- Diabetes mellitus (or fasting glucose ≥126 mg/dL at visit 1).
- Clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, or certain types of carotid artery disease.
- Presence of multiple risk factors that give a person a greater than 20% chance for developing coronary artery disease within 10 years as determined by the Framingham risk index calculated at visit 1.
- 2. Triglycerides ≥400 mg/dL at visit 1 (week -2). 3. If a smoker, subject smokes no more than 1 pack of cigarettes (20 cigarettes) per day.
- 4. Abnormal laboratory test results of clinical importance, including, but not limited to, fasting creatinine ≥1.5 mg/dL, ALT or AST ≥1.5X the upper limit of normal or fasting glucose ≥126 mg/dL at visit 1.
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- 5. Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening.
- 6. Use of any lipid-altering drugs, including statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, or prescription formulations of niacin within four weeks of visit 1 and throughout the study. 7. Use of EPA/DHA from a drug or supplement within four months of visit 1 and throughout the study period.
- 8. Frequent use of any non-study-related EPA/DHA containing enriched foods (such as DHA-enriched eggs) within four months of visit 1 and throughout the study period.
- 9. Use of flaxseed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant oil for more than one week duration within four weeks of visit 1 .
- 10. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice per month within four months of visit 1 and throughout the study period.
- 11. Use of any dietary supplement known to alter lipid metabolism. 12. Use of any weight-loss medication (prescription or over-the counter) within four weeks prior to visit 1 and throughout the study.
- 13. Use of any weight loss supplement or program within four weeks of visit 1 and throughout the study.
- 14. Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- 15. History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
- 16. History or presence of cancer, except for non-melanoma skin cancers . 17. Current or recent history of (within 12 months of visit 1, week -1) or strong potential for alcohol or substance abuse.
- 18. Use of any investigational drug within 30 days prior to visit 1. 19. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
- 20. Medications and/or supplements known to influence lipid metabolism or body weight are not allowed within four weeks of visit 1. Unstable use of antihypertensive or thyroid medication will also not be permitted.
About this study
Official title: Evaluation of the Relationships of Time and Dose of Eicosapentaenoic Acid and Stearidonic Acid to the Changes in Eicosapentaenoic Acid Levels in Red Blood Cells
The purpose of this study is to assess the relationships between dose and time of consumption of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell (RBC) membranes in men and women.
- Being tested
- Safflower Oil, EPA, SDA
- Keywords
- Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Eicosapentaenoic acid (EPA), Red blood cells, Lipids, Inflammation markers
- Medical subject headings
- Death, Sudden, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safflower OilDietary supplement
One softgel consumed daily with food
EPADietary supplement
Three different doses of EPA (0.5, 1.5 and 3.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.
SDADietary supplement
Four different doses of SDA (0.5, 1.5, 3.0 and 6.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Safflower Oil |
| EPA 0.5 g/d | Active comparator | Not described Receives: Dietary Supplement: EPA |
| EPA 1.5 g/d | Active comparator | Not described Receives: Dietary Supplement: EPA |
| EPA 3.0 g/d | Active comparator | Not described Receives: Dietary Supplement: EPA |
| SDA 0.5 g/d | Experimental | Not described Receives: Dietary Supplement: SDA |
| SDA 1.5 g/d | Experimental | Not described Receives: Dietary Supplement: SDA |
| SDA 3.0 g/d | Experimental | Not described Receives: Dietary Supplement: SDA |
| SDA 6.0 g/d | Experimental | Not described Receives: Dietary Supplement: SDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable will be the end of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids.
Measured: 12 weeks
Secondary outcomes (1)
Secondary outcome variables will include end of treatment values for: omega-3 Index (EPA + DHA as a percent of total RBC membrane fatty acids), triglycerides (TG), selected inflammatory markers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solae, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Responsible party
- Sponsor
- Investigators
- Ratna Mukherjea, PhD, Principal investigator, Solae, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038440
- Sponsor's protocol ID
- PRV-09005
- Acronym
- NK
- Status last verified
- Jun 2012
- First submitted
- 22 Dec 2009
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationships of Time and Dose of Eicosapentaenoic Acid and Stearidonic Acid to the Changes in Eicosapentaenoic Acid Levels in Red Blood Cells
- ClinicalTrials.gov ID
- NCT01038440
- Acronym / sponsor ID
- NK / PRV-09005
- Keywords
- Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Eicosapentaenoic acid (EPA), Red blood cells, Lipids, Inflammation markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Solae, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Dec 2009 (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.
The purpose of this study is to assess the relationships between dose and time of consumption of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell (RBC) membranes in men and women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Safflower Oil |
| EPA 0.5 g/d | Active comparator | Dietary Supplement: EPA |
| EPA 1.5 g/d | Active comparator | Dietary Supplement: EPA |
| EPA 3.0 g/d | Active comparator | Dietary Supplement: EPA |
| SDA 0.5 g/d | Experimental | Dietary Supplement: SDA |
| SDA 1.5 g/d | Experimental | Dietary Supplement: SDA |
| SDA 3.0 g/d | Experimental | Dietary Supplement: SDA |
| SDA 6.0 g/d | Experimental | Dietary Supplement: SDA |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 21 to 65 years of age, inclusive.
- Body mass index (BMI) 18.00-39.99 kg/m2, at visit 1 (week -2).
- Subject is willing to avoid alcohol consumption for 24 hr prior to every clinic visit.
- The subject has no plans to change smoking habits during the study period.
- Subject is willing to maintain a stable body weight, current activity level, and dietary habits except for use of the study products as directed.
Key exclusion criteria (18 listed)
- 1. Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
- Diabetes mellitus (or fasting glucose ≥126 mg/dL at visit 1).
- Clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, or certain types of carotid artery disease.
- Presence of multiple risk factors that give a person a greater than 20% chance for developing coronary artery disease within 10 years as determined by the Framingham risk index calculated at visit 1.
- 2. Triglycerides ≥400 mg/dL at visit 1 (week -2). 3. If a smoker, subject smokes no more than 1 pack of cigarettes (20 cigarettes) per day.
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 |
|---|---|---|
| Safflower OilOne softgel consumed daily with food | Dietary supplement | Control |
| EPAThree different doses of EPA (0.5, 1.5 and 3.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings. | Dietary supplement | EPA 0.5 g/d, EPA 1.5 g/d, EPA 3.0 g/d |
| SDAFour different doses of SDA (0.5, 1.5, 3.0 and 6.0 g/d) consumed with food daily.Subjects consuming more than 1 softgel/day (as in the groups with 1.5 and 3.0 g/d) are instructed to consume the softgels in 2 or 3 separate servings. | Dietary supplement | SDA 0.5 g/d, SDA 1.5 g/d, SDA 3.0 g/d, SDA 6.0 g/d |
Primary outcome
The primary outcome variable will be the end of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids.
Time frame: 12 weeks
1 secondary outcome
Secondary outcome variables will include end of treatment values for: omega-3 Index (EPA + DHA as a percent of total RBC membrane fatty acids), triglycerides (TG), selected inflammatory markers
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
- Final ManuscriptLink provided by the sponsor.
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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.
Ratna Mukherjea, PhD principal investigator
Solae, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Safflower Oil, EPA and SDA in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Solae, LLC.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome variable will be the end of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids. (time frame: 12 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 18 Jun 2012.