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Active Not Recruiting NCT05650294

Uptake of an Omega-3 Oil in Healthy Adults

Conditions: Absorption, Pharmacokinetics

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 12
Sponsor: Aker Biomarine Antarctic AS

Location: Germany

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.

Eligibility Criteria

Inclusion Criteria:Healthy males or females (1:1) aged 18 - 65 yearsCapable and willing to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent formHave a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or lessNo fish consumption at least two weeks prior to screening visitOmega-3 index (≤ 7 %)Non-smokerBMI: 18 to 32 kg/m2Exclusion Criteria:Omega-3 supplementation history within the last 4 weeksHave 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 riskHave current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to baselinePregnancy, 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/μLLeukocytes < 4,4 x 103/mm3Aspartate transaminase (AST) or alanine transaminase (ALT) within the normal rangeSerum creatine within the normal rangeor further for this study clinically relevant abnormal laboratory findings at screeningSignificant changes in lifestyle or medication (within last 2 months)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 safetyDifficulty swallowing capsules or predicted inability to swallow the study productsIndividuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 4 months before the study startsIndividuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 4 weeksA known allergy or hypersensitivity to any of the ingredients of the study productsNot willing to abstain from fish consumption or foods/oils high in omega-3 fatty acidsSubjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05650294). StuddyBuddy aggregates publicly available trial information.