AbsorptionNCT05650294
Uptake of an Omega-3 Oil in Healthy Adults
A study testing PL+ omega 3 fatty acids and FO EE fatty acids in people with Absorption and Pharmacokinetics, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption, Pharmacokinetics
- What is being tested?
- PL+ omega 3 fatty acids and FO EE fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2023to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Uptake of Two Different Omega-3 Fatty Acid Products in Healthy Subjects - a Randomized, Two-way Cross-over Study
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.
Read the 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.
- Conditions
- Absorption, Pharmacokinetics
- Being tested
- PL+ omega 3 fatty acids, FO EE fatty acids
- Keywords
- Omega 3 fatty acids, EPA, DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL+ omega 3 fatty acidsDietary supplement
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.
FO EE fatty acidsDietary supplement
A conventional fish oil food supplement containing EPA and DHA in the EE form. The dose will be 1250 mg EPA+DHA.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | This group will receive a single dose of the PL+ omega 3 fatty acids capsules first, then receive a single dose of the standard FO EE omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments. Receives: Dietary Supplement: PL+ omega 3 fatty acids; Dietary Supplement: FO EE fatty acids |
| Placebo group | Placebo comparator | This group will receive a single dose of the standard FO EE omega 3 fatty acids capsules first, then receive a single dose of the PL+ omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments. Receives: Dietary Supplement: PL+ omega 3 fatty acids; Dietary Supplement: FO EE fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products
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.
Measured: 0h-12h (on Day 1 and Day 15)
Secondary outcomes (17)
Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products
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.
Measured: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products
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.
Measured: 0h-72h (on Day 4 and Day 18)
Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products
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.
Measured: 0h-12h (on Day 1 and Day 15)
Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products
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.
Measured: 0h-12h (on Day 1 and Day 15)
Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products
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.
Measured: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products
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.
Measured: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products
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.
Measured: 0h-72h (on Day 4 and Day 18)
Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products
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.
Measured: 0h-72h (on Day 4 and Day 18)
Difference on Cmax of EPA+DHA between two products
Cmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
Difference on Cmax of EPA between two products
Cmax of EPA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
Difference on Cmax of DHA between two products
Cmax of DHA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
Difference on Tmax of EPA+DHA between two products
Tmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
Difference on Tmax of EPA between two products
Tmax of EPA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
Difference on Tmax of DHA between two products
Tmax of DHA will be calculated for both products, and the difference will be compared between the products.
Measured: Day 1 and Day 15
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
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.
Measured: Day 1 and Day 15
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
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.
Measured: Day 2 and Day 16
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
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.
Measured: Day 4 and Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start9 Jan 2023
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, two-way cross-over study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650294
- Sponsor's protocol ID
- BTS1879/22 // AKBM188H
- Status last verified
- Mar 2023
- First submitted
- 24 Nov 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Uptake of Two Different Omega-3 Fatty Acid Products in Healthy Subjects - a Randomized, Two-way Cross-over Study
- ClinicalTrials.gov ID
- NCT05650294
- Acronym / sponsor ID
- BTS1879/22 // AKBM188H
- Conditions
- Absorption, Pharmacokinetics
- Keywords
- Omega 3 fatty acids, EPA, DHA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, two-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Dietary Supplement: PL+ omega 3 fatty acids, Dietary Supplement: FO EE fatty acidsThis group will receive a single dose of the PL+ omega 3 fatty acids capsules first, then receive a single dose of the standard FO EE omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments. |
| Placebo group | Placebo comparator | Dietary Supplement: PL+ omega 3 fatty acids, Dietary Supplement: FO EE fatty acidsThis group will receive a single dose of the standard FO EE omega 3 fatty acids capsules first, then receive a single dose of the PL+ omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 %)
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PL+ omega 3 fatty acidsPL+ 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 supplement | Active group, Placebo group |
| FO EE fatty acidsA conventional fish oil food supplement containing EPA and DHA in the EE form. The dose will be 1250 mg EPA+DHA. | Dietary supplement | Active group, Placebo group |
Primary outcome
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products
Time frame: 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.
17 secondary outcomes
Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products
Time frame: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products
Time frame: 0h-72h (on Day 4 and Day 18)
Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products
Time frame: 0h-12h (on Day 1 and Day 15)
Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products
Time frame: 0h-12h (on Day 1 and Day 15)
Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products
Time frame: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products
Time frame: 0h-24h (on Day 2 and Day 16)
Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products
Time frame: 0h-72h (on Day 4 and Day 18)
Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products
Time frame: 0h-72h (on Day 4 and Day 18)
Difference on Cmax of EPA+DHA between two products
Time frame: Day 1 and Day 15
Difference on Cmax of EPA between two products
Time frame: Day 1 and Day 15
Difference on Cmax of DHA between two products
Time frame: Day 1 and Day 15
Difference on Tmax of EPA+DHA between two products
Time frame: Day 1 and Day 15
Difference on Tmax of EPA between two products
Time frame: Day 1 and Day 15
Difference on Tmax of DHA between two products
Time frame: Day 1 and Day 15
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
Time frame: Day 1 and Day 15
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
Time frame: Day 2 and Day 16
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
Time frame: Day 4 and Day 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PL+ omega 3 fatty acids and FO EE fatty acids in people with Absorption and Pharmacokinetics, run by Aker BioMarine Human Ingredients AS at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products (time frame: 0h-12h (on Day 1 and Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.