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

The Ohio State University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Healthy Diet

Treatments: Dietary Supplement: Algae Oil Capsule; Other: Algae Oil Fortified Soymilk

Study type: Interventional

Funder types: Other

Identifiers

NCT05802797

OSU-87

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Algae Oil Fortified Soymilk

Experimental group

Description:

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

Treatment:

Other: Algae Oil Fortified Soymilk

Algae Oil Supplements

Active Comparator group

Description:

Subjects will take 2 commercial algae oil capsules.

Treatment:

Dietary Supplement: Algae Oil Capsule