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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Sudden Cardiac Death; Sudden Cardiac Arrest
• Intervention / Treatment: Dietary supplement: Safflower Oil; Dietary supplement: EPA; Dietary supplement: SDA

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Dietary supplement: Safflower Oil; One softgel consumed daily with food
Active Comparator: EPA 0.5 g/d	Dietary supplement: 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.
Active Comparator: EPA 1.5 g/d	Dietary supplement: 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.
Active Comparator: EPA 3.0 g/d	Dietary supplement: 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.
Experimental: SDA 0.5 g/d	Dietary supplement: 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.
Experimental: SDA 1.5 g/d	Dietary supplement: 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.
Experimental: SDA 3.0 g/d	Dietary supplement: 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.
Experimental: SDA 6.0 g/d	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Solae, LLC
• Collaborators: Provident Clinical Research
• Investigators: Principal Investigator: Ratna Mukherjea, PhD, Solae, LLC

Publications and helpful links

Helpful Links

• Final Manuscript

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): June 18, 2012
• Last Update Submitted That Met QC Criteria: June 15, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Eicosapentaenoic acid (EPA); Lipids; Omega 3 fatty acids; Inflammation markers; Red blood cells; Omega 3 Index; Stearidonic acid (SDA)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Death, Sudden; Heart Arrest; Cardiovascular Diseases; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: PRV-09005