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Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules

Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05802797
Enrollment
24
Registered
2023-04-07
Start date
2023-04-03
Completion date
2026-07-10
Last updated
2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Diet

Keywords

Algae Oil, EPA and DHA, Omega-3 Fatty Acids

Brief summary

This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools.

Detailed description

Research shows that fish oil and its component fatty acids EPA and DHA provide health benefits such as reducing the risk of cardiac death and lowering inflammation. Yet a large portion of the population is not consuming the recommended amount of fish due to high cost, dietary restrictions such as vegetarianism/veganism, concerns about high levels of mercury, general dislike, and other factors. Additionally, to meet the recommendations fish and fish oil production present sustainability challenges. A potential alternative is to utilize EPA and DHA from algae. These sustainable oils can be added to foods increasing the potential for fatty acids to counteract chronic disease and increasing access to general consumers. Previously, our lab has developed, and optimized EPA and DHA fortified non-dairy plant milk beverages utilizing algae oil emulsions (food grade). Up to 0.4% algae oil can be added to soymilk with limited changes to overall liking. This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools. Subjects will consume either one beverage or two capsules per day, containing equivalent amounts of EPA and DHA. Blood will be taken at 4 time points throughout the 6 week study, every two weeks and analyzed for EPA and DHA in different lipid types. Additionally, participants will complete a food frequency questionnaire to evaluate their normal diet, sensory evaluation (overall liking, and attribute evaluation) of the beverages, and daily symptom and intake logs to track consumption and any side effects.

Interventions

OTHERAlgae Oil Fortified Soymilk

Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA

DIETARY_SUPPLEMENTAlgae Oil Capsule

Algae oil capsules with EPA and DHA

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

No masking.

Intervention model description

24 participants (12 men and 12 women) will be randomized to two intervention groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index between 18 and 30 kg/m2

Exclusion criteria

* Being pregnant or nursing * Having anemia or a condition that influences the ability to donate blood safely * Allergies to the beverage or pill ingredients * Diabetes * High triglycerides or cholesterol * Coagulation disorder * Anticoagulation therapy or any drug that affects blood clotting. * Taking prescribed dietary omega-3 fatty acid medications including fish oil or algae oil within the last 3 months * Taking non-prescribed dietary omega-3 fatty acid supplements within the last 3 months and not willing to discontinue taking them for the study period * Taking lipid lowering medications such as statins * Sensory impairments which affect ability to taste, smell, or see food products

Design outcomes

Primary

MeasureTime frameDescription
Erythrocyte EPA and DHA levels4 weeksPercent EPA and DHA of total fatty acids in erythrocyte samples

Secondary

MeasureTime frameDescription
Plasma EPA and DHA levels4 weeksPercent EPA and DHA of total fatty acids in plasma samples
Peripheral blood mononuclear cell (PBMC) EPA and DHA levels4 weeksPercent EPA and DHA of total fatty acids in PBMC samples

Other

MeasureTime frameDescription
Compliance4 weeksPercent of days that participants consume their beverage or pill

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026