healthy volunteers
Conditions
Interventions
Group 1: EPA & DHA as Omega-3 lysine salt, 1100 mg, single dose
Group 2: EPA & DHA in ethyl ester form, 1100 mg, single dose
Group 3: EPA & DHA in triglyceride form, 1100 mg, single dose
Sponsors
Evonik Operations GmbH | Nurition & Care
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Comparison of AUC 0-12h for EPA and DHA separately between formulations - Comparison of AUC 0-24h for EPA, DHA and EPA+DHA between formulations - Comparison of Cmax and Tmax between formulations | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed