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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Diet

Intervention / Treatment
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* Other: Algae Oil Fortified Soymilk
* Dietary Supplement: Algae Oil Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 24 participants (12 men and 12 women) will be randomized to two intervention groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Algae Oil Fortified Soymilk<br>Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk | Other: Algae Oil Fortified Soymilk<br>* Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA<br>|
| Active Comparator: Algae Oil Supplements<br>Subjects will take 2 commercial algae oil capsules. | Dietary Supplement: Algae Oil Capsule<br>* Algae oil capsules with EPA and DHA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte EPA and DHA levels | Percent EPA and DHA of total fatty acids in erythrocyte samples | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma EPA and DHA levels | Percent EPA and DHA of total fatty acids in plasma samples | 4 weeks | 
| Peripheral blood mononuclear cell (PBMC) EPA and DHA levels | Percent EPA and DHA of total fatty acids in PBMC samples | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Algae Oil, EPA and DHA, Omega-3 Fatty Acids