Bioavailability of three different Omega-3 fatty acid products in healthy subjects – a randomized, three-way cross-over study
- Conditions
- healthy volunteers
- Registration Number
- DRKS00029183
- Lead Sponsor
- Evonik Operations GmbH | Nurition & Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 21
Men and women with low consumption of fatty fish, defined as a frequency of less than twice per month
No fish consumption at least two weeks prior to screening visit
No current omega-3 or cod liver oil supplementation, nor use of flaxseeds or other plant sources of linoleic acid
Omega-3 index in erythrocytes: = 6.0%
BMI from 18.5 to 29.9 kg/m²
WHR of = 0.90 in men and = 0.85 in women
Non-smoker
(1) Diagnosis of a clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal, or biliary disorder that may interfere with the interpretation of the study results
(2) Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator’s opinion would impact subject safety
(3) Significant changes in lifestyle or medication (within last 2 months)
(4) A recent history (prior 5 years) or presence of cancer
(5) Difficulty swallowing capsules or predicted inability to swallow the study products
(6) Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 3 months before the study starts
(7) Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 3 months (i.e. no clinical study activity for 3 months)
(8) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
(9) A known allergy or hypersensitivity to any of the ingredients of the study products
(10) Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
(11) For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
(12) If female: currently pregnant, planning to become pregnant during the study period, breastfeeding (a pregnancy test will be conducted during screening and visits 1-3)
(13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method From concentration-time curve of EPA and DHA over a time period of 0-12h, determination area under the curve (AUC) and comparison between different formulations.
- Secondary Outcome Measures
Name Time Method - Comparison of AUC 0-12h for EPA and DHA separately between formulations<br>- Comparison of AUC 0-24h for EPA, DHA and EPA+DHA between formulations<br>- Comparison of Cmax and Tmax between formulations