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.
: Sunflower Oil Softgels
: EPA softgels
Other: Sunflower Oil Food
Other: SDA soybean Oil Food
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Full eligibility criteria for NCT01749202
Ages eligible for Study
21 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
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.
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).
All locations for NCT01749202
United States (1)
Provident Clinical Research &Consulting
Glen Ellyn, Illinois, United States, 60137
View full eligibility
Tris trial is registered with FDA with number: NCT01749202. The sponsor of the trial is Solae, LLC and it is looking for 126 volunteers for the current phase.
Official trial title:
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