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

This study has been completed.
Sponsor:
Collaborator:
Provident Clinical Research
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01749202
First received: June 15, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Omega-3 Index [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • SDA percent of total RBC membrane fatty acids [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Fasting insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • HOMA (IR) and HOMA (%B) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749202

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

No publications provided

Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01749202     History of Changes
Other Study ID Numbers: PRV-10001
Study First Received: June 15, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Solae, LLC:
Omega 3 fatty acids
Omega 3 Index
Stearidonic acid (SDA)
Red Blood Cells
Lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Death, Sudden, Cardiac
Heart Arrest
Death
Death, Sudden
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014