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

Solae, LLC

Status: Completed

Conditions: Sudden Cardiac Arrest; Sudden Cardiac Death; Cardiovascular Disease

Treatments: Other: Sunflower Oil Food; Dietary Supplement: EPA softgels; Other: SDA soybean Oil Food; Dietary Supplement: Sunflower Oil Softgels

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01749202

PRV-10001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 3 patient groups, including a placebo group

Negative Control

Placebo Comparator group

Treatment:

Dietary Supplement: Sunflower Oil Softgels

Other: Sunflower Oil Food

Positive Control

Active Comparator group

Treatment:

Dietary Supplement: EPA softgels

Other: Sunflower Oil Food

Active

Experimental group

Treatment:

Dietary Supplement: Sunflower Oil Softgels

Other: SDA soybean Oil Food