Clinical trial NCT05438173: Bioavailability of EPA/DHA in of Ruby-O and Krill Oil
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Lead sponsor: Midwest Center for Metabolic and Cardiovascular Research
Sponsor class: OTHER
Collaborators: name: Naturmega
First posted: 2022-06-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 to 55 y of age, inclusive.
2. Subject has a BMI of 18.50 to 29.99 kg/m2.
3. Subject has a score ≥7 on the Vein Access Scale.
4. Subject is judged by the Investigator to be in generally good health, on the basis of medical history and screening measurements.
5. Subject is willing and able to undergo the scheduled study procedures.
6. Subject agrees to abstain from consuming more than one meal containing fish per week throughout the study.
7. Subject agrees to abstain from taking fish oil or omega-3 fatty acid supplements throughout the study.
8. 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.
9. Subject is willing to abstain from alcohol consumption for at least 24 h prior to each clinic visit.
10. Subject has no plans to change smoking habits during the study.
11. 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.

Exclusion Criteria:

1. 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).
2. 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).
3. 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).
4. Subject has consumed fish oil (prescription, dietary supplement, and/or EPA and/or DHA enriched foods) within 14 days of visit 2 (day 0).
5. 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).
6. Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
7. Subject has a positive result on the urine drug screen.
8. Subject has a clinically significant medical diagnosis that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
9. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
10. Subject has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
11. 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).
12. 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.
13. Subject has a known allergy or sensitivity to any ingredients in the study products.
14. Subject has been exposed to any non-registered drug product within 30 days of the first screening visit.
15. 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).
16. 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.

Primary outcomes:
measure: Baseline-adjusted geometric mean ratio for EPA + DHA AUC
timeFrame: Baseline to 24 hours
Secondary outcomes:
measure: Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
measure: Unadjusted AUC for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
measure: Baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
measure: Baseline-adjusted AUC for EPA and DHA
timeFrame: Baseline to 24 hours
measure: Baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
measure: Baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
measure: Time to maximum concentration for EPA, DHA, and EPA + DHA
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: Port Saint Lucie
country: United States
facility: Health Awareness
state: Florida
Study officials:
affiliation: MB Clinical Research & Consulting
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References: