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

NCT01749202 | Completed DMC

• 1 other identifier: PRV-10001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease

Keywords

Omega 3 fatty acids; Omega 3 Index; Stearidonic acid (SDA); Red Blood Cells; Lipids

Outcome Measures

Primary Outcomes (1)

• End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids

  12 weeks

Secondary Outcomes (5)

• Omega-3 Index

  12 weeks

• SDA percent of total RBC membrane fatty acids

  12 weeks

• Triglycerides

  12 weeks

• Fasting insulin

  12 weeks

• HOMA (IR) and HOMA (%B)

  12 weeks

Study Arms (3)

Negative Control

PLACEBO COMPARATOR

Dietary Supplement: Sunflower Oil Softgels; Other: Sunflower Oil Food

Positive Control

ACTIVE COMPARATOR

Dietary Supplement: EPA softgels; Other: Sunflower Oil Food

Active

EXPERIMENTAL

Dietary Supplement: Sunflower Oil Softgels; Other: SDA soybean Oil Food

Interventions

Sunflower Oil Softgels DIETARY_SUPPLEMENT

3 x 500 mg softgel capsules/day

Active; Negative Control

EPA softgels DIETARY_SUPPLEMENT

3 x 500 mg softgel capsules/day

Positive Control

Sunflower Oil Food OTHER

3 servings/day

Also known as: Food

Negative Control; Positive Control

SDA soybean Oil Food OTHER

3 servings/day

Also known as: Food

Active

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.
• BMI) ≥18.00 and \<40.00 kg/m2.
• 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.
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
• No plans to change smoking habits during the study period.
• Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed.
• 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.

You may not qualify if:

• 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.
• Abnormal laboratory test results of clinical significance
• TG ≥400 mg/dL at visit 1, week -2.
• Smokes more than one pack of cigarettes (20 cigarettes) per day.
• 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.
• Uncontrolled hypertension
• Unstable use within four weeks of visit 1 (week -2) of antihypertensive medications or thyroid hormone replacement.
• 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.
• Use of EPA/DHA from a drug or supplement within four months of visit 1
• 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
• Use of seeds and oils containing a significant amount of ALA
• Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice per month

Sponsors & Collaborators

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

Study Sites (1)

Provident Clinical Research &Consulting

Glen Ellyn, Illinois, 60137, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Cardiovascular Diseases

Interventions

Food

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: December 13, 2012
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (1)