Clinical trial NCT05650294: Uptake of an Omega-3 Oil in Healthy Adults
Official title: Investigation of Uptake of Two Different Omega-3 Fatty Acid Products in Healthy Subjects - a Randomized, Two-way Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption
Pharmacokinetics
Keywords: Omega 3 fatty acids
EPA
DHA
Lead sponsor: Aker BioMarine Human Ingredients AS
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2022-12-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, two-way cross-over study
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Participants will be asked to take capsules of the new "phospholipids+" (PL+) omega-3 product (a combination product of krill oil and fish oil) in the morning with a low-fat breakfast. This product contains around 1250 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA).

Researchers will compare this group with another group that takes standard fish oil (FO) ethyl esters (EE, with the same amount of EPA+DHA) to see if there are differences in pharmacokinetic parameters, including incremental area under the curve (iAUC), the maximum concentration of (Cmax) and the time it takes for EPA, DHA and EPA+DHA to reach the maximum concentration (Tmax) in plasma.

Eligibility criteria: 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 this study clinically relevant abnormal laboratory findings at screening
* Significant 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 safety
* Difficulty swallowing capsules or predicted inability to swallow the study products
* Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 4 months before the study starts
* Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 4 weeks
* A known allergy or hypersensitivity to any of the ingredients of the study products
* Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

Primary outcomes:
measure: Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products
timeFrame: 0h-12h (on Day 1 and Day 15)
Secondary outcomes:
measure: Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products
timeFrame: 0h-24h (on Day 2 and Day 16)
measure: Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products
timeFrame: 0h-72h (on Day 4 and Day 18)
measure: Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products
timeFrame: 0h-12h (on Day 1 and Day 15)
measure: Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products
timeFrame: 0h-12h (on Day 1 and Day 15)
measure: Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products
timeFrame: 0h-24h (on Day 2 and Day 16)
measure: Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products
timeFrame: 0h-24h (on Day 2 and Day 16)
measure: Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products
timeFrame: 0h-72h (on Day 4 and Day 18)
measure: Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products
timeFrame: 0h-72h (on Day 4 and Day 18)
measure: Difference on Cmax of EPA+DHA between two products
timeFrame: Day 1 and Day 15
measure: Difference on Cmax of EPA between two products
timeFrame: Day 1 and Day 15
measure: Difference on Cmax of DHA between two products
timeFrame: Day 1 and Day 15
measure: Difference on Tmax of EPA+DHA between two products
timeFrame: Day 1 and Day 15
measure: Difference on Tmax of EPA between two products
timeFrame: Day 1 and Day 15
measure: Difference on Tmax of DHA between two products
timeFrame: Day 1 and Day 15
measure: Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 12 hours between two products
timeFrame: Day 1 and Day 15
measure: Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 24 hours between two products
timeFrame: Day 2 and Day 16
measure: Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 72 hours between two products
timeFrame: Day 4 and Day 18
Other outcomes:
measure: Number of participants with treatment-related adverse events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: Day 1 to Day 3 and Day 15 to Day 18
measure: Number of participants with abnormal blood routine parameters as assessed by clinical reference values
timeFrame: Day 1 and Day 15
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel
role: PRINCIPAL_INVESTIGATOR
References: