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

NCT01038440 | Completed DMC

• 1 other identifier: PRV-09005
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease

Keywords

Omega 3 fatty acids; Omega 3 Index; Stearidonic acid (SDA); Eicosapentaenoic acid (EPA); Red blood cells; Lipids; Inflammation markers

Outcome Measures

Primary Outcomes (1)

• 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 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

  12 weeks

Study Arms (8)

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

Interventions

Safflower Oil DIETARY_SUPPLEMENT

One softgel consumed daily with food

Control

EPA DIETARY_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.

EPA 0.5 g/d; EPA 1.5 g/d; EPA 3.0 g/d

SDA DIETARY_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.

SDA 0.5 g/d; SDA 1.5 g/d; SDA 3.0 g/d; SDA 6.0 g/d

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening.
• \. 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.
• \. 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.
• \. 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 .
• \. 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.
• \. 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.
• \. Use of any weight loss supplement or program within four weeks of visit 1 and throughout the study.
• \. 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.
• \. History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.

Sponsors & Collaborators

• Solae, LLC: lead
• Provident Clinical Research: collaborator

Related Links

• Final Manuscript

MeSH Terms

Conditions

Death, Sudden, Cardiac; Cardiovascular Diseases

Interventions

Safflower Oil

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ratna Mukherjea, PhD

  Solae, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 18, 2012

Record last verified: 2012-06