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

NCT ID: NCT05802797

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2026-07-10

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.

Conditions

Healthy Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Algae Oil Fortified Soymilk

Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk

Group Type: EXPERIMENTAL

Algae Oil Fortified Soymilk

Intervention Type: OTHER

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

Algae Oil Supplements

Subjects will take 2 commercial algae oil capsules.

Group Type: ACTIVE_COMPARATOR

Algae Oil Capsule

Intervention Type: DIETARY_SUPPLEMENT

Algae oil capsules with EPA and DHA

Interventions

Algae Oil Fortified Soymilk

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

Intervention Type: OTHER

Algae Oil Capsule

Algae oil capsules with EPA and DHA

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Yael Vodovotz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yael Vodovotz, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OSU-87

Identifier Type: -

Identifier Source: org_study_id