Sudden Cardiac DeathNCT01749202
Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
A study testing Sunflower Oil Softgels, EPA softgels and Sunflower Oil Food in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Solae, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of stearidonic acid when used as a food ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index 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?
- Sunflower Oil Softgels, EPA softgels and Sunflower Oil Food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2011
- 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.
- BMI) ≥18.00 and <40.00 kg/m2.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
- No plans to change smoking habits during the study period.
- Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
- Diabetes mellitus
- Clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, 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.
- Abnormal laboratory test results of clinical significance
- TG ≥400 mg/dL at visit 1, week -2.
Show all 24Show fewer
- Smokes more than one pack of cigarettes (20 cigarettes) per day.
- History or presence of clinically important renal, hepatic, pulmonary, biliary, gastrointestinal, neurologic or endocrine disorders that in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol Stable, treated hypothyroidism is allowed.
- Uncontrolled hypertension
- Unstable use within four weeks of visit 1 (week -2) of antihypertensive medications or thyroid hormone replacement.
- 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 (week -2) and throughout the study. If a subject needs to wash off of a drug, he/she will be consented and then asked to return after the four week washout.
- Use of EPA/DHA from a drug or supplement within four months of visit 1
- Frequent use (more than twice per month) of any non-study-related EPA/DHA containing enriched foods (such as DHA-enriched eggs) within four months of visit 1, week -2 and avoidance of these enriched foods throughout the study period
- Use of seeds and oils containing a significant amount of ALA
- Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice per month
- Use of any dietary supplement known to alter lipid metabolism
- Use of any weight-loss medication
- Use of any weight loss supplement or program within four weeks of visit 1
- Known allergy or sensitivity to study products or any ingredients of the study products.
- Subject is unwilling to consume the study products (bars, beverages and capsules) based on results from the taste testing of the study products at visit 1, week -2.
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
- 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. The method of contraception must be recorded in the source documentation.
- Current or recent history of (within 12 months of visit 1, week -2) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
- Exposure to any non-registered drug product within 30 days prior to the screening visit (visit 1, week -2).
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research &Consulting
Glen Ellyn, Illinois, 60137
About this study
The purpose of this study is to assess the effect of stearidonic acid when used as a food ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in men and women.
- Being tested
- Sunflower Oil Softgels, EPA softgels, Sunflower Oil Food, SDA soybean Oil Food
- Keywords
- Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Red Blood Cells, Lipids
- 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.
Sunflower Oil SoftgelsDietary supplement
3 x 500 mg softgel capsules/day
EPA softgelsDietary supplement
3 x 500 mg softgel capsules/day
Sunflower Oil FoodOther
Also called Food
3 servings/day
SDA soybean Oil FoodOther
Also called Food
3 servings/day
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | Placebo comparator | Not described Receives: Dietary Supplement: Sunflower Oil Softgels; Other: Sunflower Oil Food |
| Positive Control | Active comparator | Not described Receives: Dietary Supplement: EPA softgels; Other: Sunflower Oil Food |
| Active | Experimental | Not described Receives: Dietary Supplement: Sunflower Oil Softgels; Other: SDA soybean Oil Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids
Measured: 12 weeks
Secondary outcomes (5)
Omega-3 Index
Measured: 12 weeks
SDA percent of total RBC membrane fatty acids
Measured: 12 weeks
Triglycerides
Measured: 12 weeks
Fasting insulin
Measured: 12 weeks
HOMA (IR) and HOMA (%B)
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 posted13 Dec 2012 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionDec 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 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
- NCT01749202
- Sponsor's protocol ID
- PRV-10001
- Status last verified
- Dec 2012
- First submitted
- 15 Jun 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
- ClinicalTrials.gov ID
- NCT01749202
- Acronym / sponsor ID
- PRV-10001
- Keywords
- Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Red Blood Cells, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Solae, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Dec 2012 (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 effect of stearidonic acid when used as a food ingredient on eicosapentaenoic enrichment of red blood cell membranes and Omega-3 Index in men and women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control | Placebo comparator | Dietary Supplement: Sunflower Oil Softgels, Other: Sunflower Oil Food |
| Positive Control | Active comparator | Dietary Supplement: EPA softgels, Other: Sunflower Oil Food |
| Active | Experimental | Dietary Supplement: Sunflower Oil Softgels, Other: SDA soybean Oil Food |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 21 to 65 years of age.
- BMI) ≥18.00 and <40.00 kg/m2.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
- No plans to change smoking habits during the study period.
Key exclusion criteria (24 listed)
- Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
- Abnormal laboratory test results of clinical significance
- TG ≥400 mg/dL at visit 1, week -2.
- Smokes more than one pack of cigarettes (20 cigarettes) per day.
- History or presence of clinically important renal, hepatic, pulmonary, biliary, gastrointestinal, neurologic or endocrine disorders that in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol Stable, treated hypothyroidism is allowed.
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 |
|---|---|---|
| Sunflower Oil Softgels3 x 500 mg softgel capsules/day | Dietary supplement | Active, Negative Control |
| EPA softgels3 x 500 mg softgel capsules/day | Dietary supplement | Positive Control |
| Sunflower Oil FoodAlso: Food3 servings/day | Other | Negative Control, Positive Control |
| SDA soybean Oil FoodAlso: Food3 servings/day | Other | Active |
Primary outcome
End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids
Time frame: 12 weeks
5 secondary outcomes
Omega-3 Index
Time frame: 12 weeks
SDA percent of total RBC membrane fatty acids
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Fasting insulin
Time frame: 12 weeks
HOMA (IR) and HOMA (%B)
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 13 Dec 2012.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunflower Oil Softgels, EPA softgels and Sunflower Oil Food in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Solae, LLC 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 7 inclusion and 24 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 13 Dec 2012. 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 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?
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 13 Dec 2012.