BioavailabilityNCT05438173
Bioavailability of EPA/DHA in of Ruby-O and Krill Oil
A study testing EPA + DHA Ruby-O and EPA + DHA Krill Oil in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this study is to assess the relative bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and women. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- EPA + DHA Ruby-O and EPA + DHA Krill Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 18 Sep 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 55 y of age, inclusive.
- Subject has a BMI of 18.50 to 29.99 kg/m2.
- Subject has a score ≥7 on the Vein Access Scale.
- Subject is judged by the Investigator to be in generally good health, on the basis of medical history and screening measurements.
- Subject is willing and able to undergo the scheduled study procedures.
- Subject agrees to abstain from consuming more than one meal containing fish per week throughout the study.
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- Subject agrees to abstain from taking fish oil or omega-3 fatty acid supplements throughout the study.
- Subject is willing to maintain usual physical activity levels for the duration of the study and not to engage in vigorous physical activity for at least 24 h prior to each clinic visit.
- Subject is willing to abstain from alcohol consumption for at least 24 h prior to each clinic visit.
- Subject has no plans to change smoking habits during the study.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject has consumed more than one meal per week containing fish or seafood within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- Subject has taken a fish oil or omega-3 fatty acid supplement within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- Subject has consumed high-dose fish oil ≥1 g/d of EPA + DHA (the sum of EPA and DHA components from prescription or supplement forms) within 3 months prior to visit 2 (day 0).
- Subject has consumed fish oil (prescription, dietary supplement, and/or EPA and/or DHA enriched foods) within 14 days of visit 2 (day 0).
- Individual has used prescribed medication or over-the-counter medicinal products, including herbal and dietary supplements (EXCEPT for a daily omega-3 fatty acid-free vitamin and/or mineral supplement or the occasional use of acetaminophen or nonsteroidal anti-inflammatory drugs (such as ibuprofen or naproxen) within 14 days prior to visit 2 (day 0).
- Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
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- Subject has a positive result on the urine drug screen.
- Subject has a clinically significant medical diagnosis that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
- Subject has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- Subject has signs or symptoms of an active infection of clinical relevance, or has taken antibiotics, within 14 days prior to any visit (washout is permitted).
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Subject has a known allergy or sensitivity to any ingredients in the study products.
- Subject has been exposed to any non-registered drug product within 30 days of the first screening visit.
- Subject has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Crossover, Kinetic Study to Assess the Relative Bioavailability of Omega-3 Fatty Acids in Two Supplement Products in Healthy Adult Men and Women
The objective of this study is to assess the relative bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and women.
- Conditions
- Bioavailability
- Being tested
- EPA + DHA Ruby-O, EPA + DHA Krill Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA + DHA Ruby-ODietary supplement
Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule
EPA + DHA Krill OilDietary supplement
Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule
| Study group | Role | What they receive |
|---|---|---|
| EPA + DHA Ruby-O | Experimental | Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule Receives: Dietary Supplement: EPA + DHA Ruby-O |
| EPA + DHA Krill Oil | Active comparator | Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule Receives: Dietary Supplement: EPA + DHA Krill Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted geometric mean ratio for EPA + DHA AUC
Changes in baseline-adjusted geometric mean ratio for EPA + DHA AUC
Measured: Baseline to 24 hours
Secondary outcomes (7)
Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA
Changes in unadjusted maximum concentrations for EPA, DHA, and EPA + DHA
Measured: Baseline to 24 hours
Unadjusted AUC for EPA, DHA, and EPA + DHA
Changes in unadjusted AUC for EPA, DHA, and EPA + DHA
Measured: Baseline to 24 hours
Baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA
Changes in baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA
Measured: Baseline to 24 hours
Baseline-adjusted AUC for EPA and DHA
Changes in baseline-adjusted AUC for EPA and DHA
Measured: Baseline to 24 hours
Baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA
Changes in baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA
Measured: Baseline to 24 hours
Baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA
Changes in baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA
Measured: Baseline to 24 hours
Time to maximum concentration for EPA, DHA, and EPA + DHA
Changes in time to maximum concentration for EPA
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start11 Jul 2022
- Primary completion18 Sep 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Naturmega
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, MB Clinical Research & Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438173
- Sponsor's protocol ID
- MB-2201
- Status last verified
- Nov 2022
- First submitted
- 24 Jun 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover, Kinetic Study to Assess the Relative Bioavailability of Omega-3 Fatty Acids in Two Supplement Products in Healthy Adult Men and Women
- ClinicalTrials.gov ID
- NCT05438173
- Acronym / sponsor ID
- MB-2201
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Naturmega
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 18 Sep 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 29 Jun 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 objective of this study is to assess the relative bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA + DHA Ruby-O | Experimental | Dietary Supplement: EPA + DHA Ruby-OSubject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule |
| EPA + DHA Krill Oil | Active comparator | Dietary Supplement: EPA + DHA Krill OilSubject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, 18 to 55 y of age, inclusive.
- Subject has a BMI of 18.50 to 29.99 kg/m2.
- Subject has a score ≥7 on the Vein Access Scale.
- Subject is judged by the Investigator to be in generally good health, on the basis of medical history and screening measurements.
- Subject is willing and able to undergo the scheduled study procedures.
Key exclusion criteria (16 listed)
- Subject has consumed more than one meal per week containing fish or seafood within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- Subject has taken a fish oil or omega-3 fatty acid supplement within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- Subject has consumed high-dose fish oil ≥1 g/d of EPA + DHA (the sum of EPA and DHA components from prescription or supplement forms) within 3 months prior to visit 2 (day 0).
- Subject has consumed fish oil (prescription, dietary supplement, and/or EPA and/or DHA enriched foods) within 14 days of visit 2 (day 0).
- Individual has used prescribed medication or over-the-counter medicinal products, including herbal and dietary supplements (EXCEPT for a daily omega-3 fatty acid-free vitamin and/or mineral supplement or the occasional use of acetaminophen or nonsteroidal anti-inflammatory drugs (such as ibuprofen or naproxen) within 14 days prior to visit 2 (day 0).
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 |
|---|---|---|
| EPA + DHA Ruby-OSubject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule | Dietary supplement | EPA + DHA Ruby-O |
| EPA + DHA Krill OilSubject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule | Dietary supplement | EPA + DHA Krill Oil |
Primary outcome
Baseline-adjusted geometric mean ratio for EPA + DHA AUC
Time frame: Baseline to 24 hours
Changes in baseline-adjusted geometric mean ratio for EPA + DHA AUC
7 secondary outcomes
Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
Unadjusted AUC for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
Baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
Baseline-adjusted AUC for EPA and DHA
Time frame: Baseline to 24 hours
Baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
Baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
Time to maximum concentration for EPA, DHA, and EPA + DHA
Time frame: Baseline to 24 hours
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 1 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Kevin C Maki, PhD study director
MB Clinical Research & Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA + DHA Ruby-O and EPA + DHA Krill Oil in people with Bioavailability, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
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 11 inclusion and 16 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 1 Dec 2022. 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 United States. 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. 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?
Baseline-adjusted geometric mean ratio for EPA + DHA AUC (time frame: Baseline to 24 hours). 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 1 Dec 2022.