Bioavailability of EPA/DHA in of Ruby-O and Krill Oil

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: EPA + DHA Ruby-O; Dietary supplement: EPA + DHA Krill Oil

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Health Awareness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPA + DHA Ruby-O; Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule	Dietary supplement: EPA + DHA Ruby-O; Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule
Active Comparator: EPA + DHA Krill Oil; Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule	Dietary supplement: EPA + DHA Krill Oil; Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline-adjusted geometric mean ratio for EPA + DHA AUC	Changes in baseline-adjusted geometric mean ratio for EPA + DHA AUC	Baseline to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA	Changes in unadjusted maximum concentrations for EPA, DHA, and EPA + DHA	Baseline to 24 hours
Unadjusted AUC for EPA, DHA, and EPA + DHA	Changes in unadjusted AUC for EPA, DHA, and EPA + DHA	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	Baseline to 24 hours
Baseline-adjusted AUC for EPA and DHA	Changes in baseline-adjusted AUC for EPA and DHA	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	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	Baseline to 24 hours
Time to maximum concentration for EPA, DHA, and EPA + DHA	Changes in time to maximum concentration for EPA	Baseline to 24 hours

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: Naturmega

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): September 18, 2022
• Study Completion (Actual): September 18, 2022

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MB-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No