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

Healthy Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802797
• Other study ID #: OSU-87
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 3, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Yael Vodovotz, PhD
• Phone: 614-247-7696
• Email: vodovotz.1[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Diet

Intervention

Other:
• Algae Oil Fortified Soymilk
Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA

Dietary Supplement:
• Algae Oil Capsule
Algae oil capsules with EPA and DHA

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance	Percent of days that participants consume their beverage or pill	4 weeks
Primary	Erythrocyte EPA and DHA levels	Percent EPA and DHA of total fatty acids in erythrocyte samples	4 weeks
Secondary	Plasma EPA and DHA levels	Percent EPA and DHA of total fatty acids in plasma samples	4 weeks
Secondary	Peripheral blood mononuclear cell (PBMC) EPA and DHA levels	Percent EPA and DHA of total fatty acids in PBMC samples	4 weeks