Time and Dose Evaluation of Stearidonic Acid (SDA) to Eicosapentaenoic Acid (EPA) in Red Blood Cells

Cardiovascular Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038440
• Other study ID #: PRV-09005
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: June 15, 2012
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: Solae, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female, 21 to 65 years of age, inclusive.

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:

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest
• Sudden Cardiac Death

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Solae, LLC	Provident Clinical Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	Yes
Secondary	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		12 weeks	Yes

External Links

•   Final Manuscript