Absorption, Pharmacokinetics
Conditions
Keywords
Omega 3 fatty acids, EPA, DHA
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.
Interventions
DIETARY_SUPPLEMENTPL+ omega 3 fatty acids
PL+ omega 3 fatty acids is a food supplement that combines krill oil and FO EE. The dose will be around 1250 mg EPA+DHA.
DIETARY_SUPPLEMENTFO EE fatty acids
A conventional fish oil food supplement containing EPA and DHA in the EE form. The dose will be 1250 mg EPA+DHA.
Sponsors
BioTeSys GmbH
Aker BioMarine Human Ingredients AS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The clinical study will be performed unblinded. However, analysis of blood samples at analysis partner will be performed blinded. After closure of data base, data will be unblinded and evaluated according to product affiliation.
Intervention model description
randomized, two-way cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products | 0h-12h (on Day 1 and Day 15) | Blood concentrations of EPA + DHA in plasma at 0h and 12h will be analyzed, and determination of iAUC0-12h will be calculated. After getting the iAUC0-12h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 12h is defined as 12 hours after the intake of supplement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products | 0h-24h (on Day 2 and Day 16) | Blood concentrations for EPA+DHA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 24h is defined as 24 hours after the intake of supplement. |
| Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products | 0h-72h (on Day 4 and Day 18) | Blood concentrations for EPA+DHA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 72h is defined as 72 hours after the intake of supplement. |
| Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products | 0h-12h (on Day 1 and Day 15) | Blood concentrations for EPA in plasma at 0h and 12h will be analyzed, and iAUC0-12h will be calculated. After getting the iAUC0-12h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 12h is defined as 12 hours after the intake of supplement. |
| Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products | 0h-12h (on Day 1 and Day 15) | Blood concentrations for DHA in plasma at 0h and 12h will be analyzed, and iAUC0-12h will be calculated. After getting the iAUC0-12h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 12h is defined as 12 hours after the intake of supplement. |
| Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products | 0h-24h (on Day 2 and Day 16) | Blood concentrations for EPA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 24h is defined as 24 hours after the intake of supplement. |
| Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products | 0h-24h (on Day 2 and Day 16) | Blood concentrations for DHA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 24h is defined as 24 hours after the intake of supplement. |
| Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products | 0h-72h (on Day 4 and Day 18) | Blood concentrations for EPA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 72h is defined as 72 hours after the intake of supplement. |
| Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products | 0h-72h (on Day 4 and Day 18) | Blood concentrations for DHA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 72h is defined as 72 hours after the intake of supplement. |
| Difference on Cmax of EPA+DHA between two products | Day 1 and Day 15 | Cmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products. |
| 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 | Day 2 and Day 16 | Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products. The time point 24h is defined as 24 hours after the intake of supplement. |
| 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 | Day 4 and Day 18 | Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products. The time point 72h is defined as 72 hours after the intake of supplement. |
| Difference on Cmax of EPA between two products | Day 1 and Day 15 | Cmax of EPA will be calculated for both products, and the difference will be compared between the products. |
| Difference on Cmax of DHA between two products | Day 1 and Day 15 | Cmax of DHA will be calculated for both products, and the difference will be compared between the products. |
| Difference on Tmax of EPA+DHA between two products | Day 1 and Day 15 | Tmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products. |
| Difference on Tmax of EPA between two products | Day 1 and Day 15 | Tmax of EPA will be calculated for both products, and the difference will be compared between the products. |
| Difference on Tmax of DHA between two products | Day 1 and Day 15 | Tmax of DHA will be calculated for both products, and the difference will be compared between the products. |
| 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 | Day 1 and Day 15 | Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products. The time point 12h is defined as 12 hours after the intake of supplement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 1 to Day 3 and Day 15 to Day 18 | During the study period, any changes in physical conditions will be evaluated by investigator using CTCAE v4.0 criteria and will be recorded as AEs or serious adverse events (SAEs). Number of participants with treatment-related AEs and SAEs will be reported to sponsor listed in the study report. |
| Number of participants with abnormal blood routine parameters as assessed by clinical reference values | Day 1 and Day 15 | During the study, blood samples from 2h sample time point will be used for safety check. The following parameters will be assessed: AST, ALT, gammaglutamyltransferase, alkaline phosphatase, total cholesterol, low-density lipoprotein- and high-density lipoprotein-cholesterol, triglycerides; creatinine and uric acid. Participants with abnormal values of any of the above-mentioned parameters that fall out of the clinical reference range will be listed and reported. |
Countries
Germany
Outcome results
None listed