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| Name | Class |
|---|---|
| Provident Clinical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Control | Placebo Comparator |
| |
| Positive Control | Active Comparator |
| |
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunflower Oil Softgels | Dietary Supplement | 3 x 500 mg softgel capsules/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| End of treatment EPA level in RBC membranes, expressed as a percent of total RBC membrane fatty acids | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Omega-3 Index | 12 weeks | |
| SDA percent of total RBC membrane fatty acids | 12 weeks | |
| Triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Ratna Mukherjea, PhD | Solae, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident Clinical Research &Consulting | Glen Ellyn | Illinois | 60137 | United States |
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| EPA softgels | Dietary Supplement | 3 x 500 mg softgel capsules/day |
|
| Sunflower Oil Food | Other | 3 servings/day |
|
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| SDA soybean Oil Food | Other | 3 servings/day |
|
|
| 12 weeks |
| Fasting insulin | 12 weeks |
| HOMA (IR) and HOMA (%B) | 12 weeks |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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