Uptake of an Omega-3 Oil in Healthy Adults (NCT05650294) | Clinical Trial Compass
CompletedNot Applicable
Uptake of an Omega-3 Oil in Healthy Adults
Germany12 participantsStarted 2023-01-09
Plain-language summary
The goal of this clinical trial is to compare the uptake of two different omega-3 fatty acid preparations in healthy adults. The main question it aims to answer is whether the two different preparations have the same uptake after single dose supplementation.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Healthy males or females (1:1) aged 18 - 65 years
* Capable and willing to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
* No fish consumption at least two weeks prior to screening visit
* Omega-3 index (≤ 7 %)
* Non-smoker
* BMI: 18 to 32 kg/m2
Exclusion Criteria:
* Omega-3 supplementation history within the last 4 weeks
* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases, i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious diseases which could confound the results of the study or put the subject at undue risk
* Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to baseline
* Pregnancy, breast feeding or intention to become pregnant during the study (a pregnancy test will be conducted during screening and visits 1-2)
* General Safety \& Laboratory Exclusion Criteria. Patients will be excluded from the study based on the following criteria:
* Haemoglobin: \< 12.0 g/dL (women); \< 13.5 g/dL (men)
* Platelets: \< 150 x 103/μL
* Leukocytes \< 4,4 x 103/mm3
* Aspartate transaminase (AST) or alanine transaminase (ALT) within the normal range
* Serum creatine within the normal range
* or further for t…
What they're measuring
1
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products