Time and Dose Evaluation of Stearidonic Acid (SDA) to Eicosapentaenoic Acid (EPA) in Red Blood Cells
NCT ID: NCT01038440
Last Updated: 2012-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2009-08-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Safflower Oil
One softgel consumed daily with food
EPA 0.5 g/d
EPA
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.
EPA 1.5 g/d
EPA
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.
EPA 3.0 g/d
EPA
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.
SDA 0.5 g/d
SDA
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.
SDA 1.5 g/d
SDA
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.
SDA 3.0 g/d
SDA
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.
SDA 6.0 g/d
SDA
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.
Interventions
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Safflower Oil
One softgel consumed daily with food
EPA
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.
SDA
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.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) 18.00-39.99 kg/m2, at visit 1 (week -2).
3. Subject is willing to avoid alcohol consumption for 24 hr prior to every clinic visit.
4. The subject has no plans to change smoking habits during the study period.
5. Subject is willing to maintain a stable body weight, current activity level, and dietary habits except for use of the study products as directed.
6. 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.
Exclusion Criteria
* 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.
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.
21 Years
65 Years
ALL
Yes
Sponsors
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Provident Clinical Research
OTHER
Solae, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Ratna Mukherjea, PhD
Role: PRINCIPAL_INVESTIGATOR
Solae, LLC
Related Links
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Final Manuscript
Other Identifiers
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PRV-09005
Identifier Type: -
Identifier Source: org_study_id
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