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

NCT05802797 | Active Not Recruiting Early Phase 1

• 1 other identifier: OSU-87
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Erythrocyte EPA and DHA levels

  Percent EPA and DHA of total fatty acids in erythrocyte samples

  4 weeks

Secondary Outcomes (2)

• Plasma EPA and DHA levels

  4 weeks

• Peripheral blood mononuclear cell (PBMC) EPA and DHA levels

  4 weeks

Other Outcomes (1)

• Compliance

  4 weeks

Study Arms (2)

Algae Oil Fortified Soymilk

EXPERIMENTAL

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

Other: Algae Oil Fortified Soymilk

Algae Oil Supplements

ACTIVE COMPARATOR

Subjects will take 2 commercial algae oil capsules.

Dietary Supplement: Algae Oil Capsule

Interventions

Algae Oil Fortified Soymilk OTHER

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

Algae Oil Fortified Soymilk

Algae Oil Capsule DIETARY_SUPPLEMENT

Algae oil capsules with EPA and DHA

Algae Oil Supplements

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index between 18 and 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Yael Vodovotz, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 7, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)