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Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749202
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : December 13, 2012
Provident Clinical Research
Information provided by (Responsible Party):
Solae, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Sudden Cardiac Arrest Cardiovascular Disease Dietary Supplement: Sunflower Oil Softgels Dietary Supplement: EPA softgels Other: Sunflower Oil Food Other: SDA soybean Oil Food Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : August 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Placebo Comparator: Negative Control Dietary Supplement: Sunflower Oil Softgels
3 x 500 mg softgel capsules/day

Other: Sunflower Oil Food
3 servings/day
Other Name: Food

Active Comparator: Positive Control Dietary Supplement: EPA softgels
3 x 500 mg softgel capsules/day

Other: Sunflower Oil Food
3 servings/day
Other Name: Food

Experimental: Active Dietary Supplement: Sunflower Oil Softgels
3 x 500 mg softgel capsules/day

Other: SDA soybean Oil Food
3 servings/day
Other Name: Food

Primary Outcome Measures :
  1. End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Omega-3 Index [ Time Frame: 12 weeks ]
  2. SDA percent of total RBC membrane fatty acids [ Time Frame: 12 weeks ]
  3. Triglycerides [ Time Frame: 12 weeks ]
  4. Fasting insulin [ Time Frame: 12 weeks ]
  5. HOMA (IR) and HOMA (%B) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female, 21 to 65 years of age.
  2. BMI) ≥18.00 and <40.00 kg/m2.
  3. 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.
  4. Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
  5. No plans to change smoking habits during the study period.
  6. Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Abnormal laboratory test results of clinical significance
  3. TG ≥400 mg/dL at visit 1, week -2.
  4. Smokes more than one pack of cigarettes (20 cigarettes) per day.
  5. 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.
  6. Uncontrolled hypertension
  7. Unstable use within four weeks of visit 1 (week -2) of antihypertensive medications or thyroid hormone replacement.
  8. 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.
  9. Use of EPA/DHA from a drug or supplement within four months of visit 1
  10. 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
  11. Use of seeds and oils containing a significant amount of ALA
  12. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice per month
  13. Use of any dietary supplement known to alter lipid metabolism
  14. Use of any weight-loss medication
  15. Use of any weight loss supplement or program within four weeks of visit 1
  16. Known allergy or sensitivity to study products or any ingredients of the study products.
  17. 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.
  18. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
  19. 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.
  20. 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).
  21. Exposure to any non-registered drug product within 30 days prior to the screening visit (visit 1, week -2).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749202

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United States, Illinois
Provident Clinical Research &Consulting
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
Solae, LLC
Provident Clinical Research
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Principal Investigator: Ratna Mukherjea, PhD Solae, LLC

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Responsible Party: Solae, LLC Identifier: NCT01749202    
Other Study ID Numbers: PRV-10001
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012
Keywords provided by Solae, LLC:
Omega 3 fatty acids
Omega 3 Index
Stearidonic acid (SDA)
Red Blood Cells
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Cardiovascular Diseases
Heart Arrest
Heart Diseases
Pathologic Processes
Death, Sudden