Clinical trial NCT05802797: Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules
Official title: Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy Diet
Keywords: Algae Oil
EPA and DHA
Omega-3 Fatty Acids
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 24 participants (12 men and 12 women) will be randomized to two intervention groups.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Erythrocyte EPA and DHA levels
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma EPA and DHA levels
timeFrame: 4 weeks
measure: Peripheral blood mononuclear cell (PBMC) EPA and DHA levels
timeFrame: 4 weeks
Other outcomes:
measure: Compliance
timeFrame: 4 weeks
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Yael Vodovotz, PhD
role: PRINCIPAL_INVESTIGATOR
References: