Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
Primary Purpose
Sudden Cardiac Death, Sudden Cardiac Arrest, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunflower Oil Softgels
EPA softgels
Sunflower Oil Food
SDA soybean Oil Food
Sponsored by
About this trial
This is an interventional prevention trial for Sudden Cardiac Death focused on measuring Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Red Blood Cells, Lipids
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- Use of any dietary supplement known to alter lipid metabolism
- Use of any weight-loss medication
- Use of any weight loss supplement or program within four weeks of visit 1
- Known allergy or sensitivity to study products or any ingredients of the study products.
- 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.
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
- 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.
- 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).
- Exposure to any non-registered drug product within 30 days prior to the screening visit (visit 1, week -2).
Sites / Locations
- Provident Clinical Research &Consulting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Negative Control
Positive Control
Active
Arm Description
Outcomes
Primary Outcome Measures
End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids
Secondary Outcome Measures
Omega-3 Index
SDA percent of total RBC membrane fatty acids
Triglycerides
Fasting insulin
HOMA (IR) and HOMA (%B)
Full Information
NCT ID
NCT01749202
First Posted
June 15, 2012
Last Updated
December 11, 2012
Sponsor
Solae, LLC
Collaborators
Provident Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT01749202
Brief Title
Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solae, LLC
Collaborators
Provident Clinical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death, Sudden Cardiac Arrest, Cardiovascular Disease
Keywords
Omega 3 fatty acids, Omega 3 Index, Stearidonic acid (SDA), Red Blood Cells, Lipids
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Control
Arm Type
Placebo Comparator
Arm Title
Positive Control
Arm Type
Active Comparator
Arm Title
Active
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower Oil Softgels
Intervention Description
3 x 500 mg softgel capsules/day
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA softgels
Intervention Description
3 x 500 mg softgel capsules/day
Intervention Type
Other
Intervention Name(s)
Sunflower Oil Food
Other Intervention Name(s)
Food
Intervention Description
3 servings/day
Intervention Type
Other
Intervention Name(s)
SDA soybean Oil Food
Other Intervention Name(s)
Food
Intervention Description
3 servings/day
Primary Outcome Measure Information:
Title
End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Omega-3 Index
Time Frame
12 weeks
Title
SDA percent of total RBC membrane fatty acids
Time Frame
12 weeks
Title
Triglycerides
Time Frame
12 weeks
Title
Fasting insulin
Time Frame
12 weeks
Title
HOMA (IR) and HOMA (%B)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Use of any dietary supplement known to alter lipid metabolism
Use of any weight-loss medication
Use of any weight loss supplement or program within four weeks of visit 1
Known allergy or sensitivity to study products or any ingredients of the study products.
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.
Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
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.
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).
Exposure to any non-registered drug product within 30 days prior to the screening visit (visit 1, week -2).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratna Mukherjea, PhD
Organizational Affiliation
Solae, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Provident Clinical Research &Consulting
City
Glen Ellyn
State/Province
Illinois
ZIP/Postal Code
60137
Country
United States
12. IPD Sharing Statement
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Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels in Red Blood Cells and Omega-3 Index
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