NCT Number: NCT02427373
A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy,
- adult female who is neither pregnant nor breastfeeding, or
- a healthy, adult male
- with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
- with a minimum weight of 50 kg (110 lbs).
Exclusion criteria
- history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
- clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
- history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
- history of coagulation disorder or current anticoagulation therapy;
- has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
- has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
Treatment and study plan
fish oil triglyceride
Dietary SupplementKrill oil
Dietary SupplementPrimary outcomes
-
Comparison of total plasma DHA+EPA levels across 3 treatment groups
Time frame: 4 weeks
Secondary outcomes
-
Comparison of RBC DHA+EPA levels across 3 treatment groups
Time frame: 4 weeks
-
pharmacokinetic parameter: AUC to 672hr
Time frame: 4 weeks
-
pharmacokinetic parameter: AUC to 336hr
Time frame: 2 weeks
-
pharmacokinetic parameter: Cmax
Time frame: 4 weeks
-
pharmacokinetic parameter: Tmax
Time frame: 4 weeks
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Lead sponsor
dsm-firmenich Switzerland AG
Industry
Registry information
Acronym: KOMPARE
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Apr 28, 2015
- Registry last updated
- Apr 28, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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