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NCT Number: NCT05802797

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algae Oil Fortified Soymilk

Other

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

Algae Oil Capsule

Dietary Supplement

Algae oil capsules with EPA and DHA

Primary outcomes

  1. Erythrocyte EPA and DHA levels

    Time frame: 4 weeks

    Percent EPA and DHA of total fatty acids in erythrocyte samples

Secondary outcomes

  1. Plasma EPA and DHA levels

    Time frame: 4 weeks

    Percent EPA and DHA of total fatty acids in plasma samples

  2. Peripheral blood mononuclear cell (PBMC) EPA and DHA levels

    Time frame: 4 weeks

    Percent EPA and DHA of total fatty acids in PBMC samples

Other outcomes

  1. Compliance

    Time frame: 4 weeks

    Percent of days that participants consume their beverage or pill

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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