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

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749202
• Other study ID #: PRV-10001
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: December 11, 2012
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: December 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• 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.

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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:
• Sunflower Oil Softgels
3 x 500 mg softgel capsules/day
• EPA softgels
3 x 500 mg softgel capsules/day

Other:
• Sunflower Oil Food
3 servings/day
• SDA soybean Oil Food
3 servings/day

Locations

Country	Name	City	State
United States	Provident Clinical Research &Consulting	Glen Ellyn	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Solae, LLC	Provident Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids		12 weeks	Yes
Secondary	Omega-3 Index		12 weeks	Yes
Secondary	SDA percent of total RBC membrane fatty acids		12 weeks	Yes
Secondary	Triglycerides		12 weeks	Yes
Secondary	Fasting insulin		12 weeks	Yes
Secondary	HOMA (IR) and HOMA (%B)		12 weeks	Yes