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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Algae Oil Fortified Soymilk | Experimental | Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk |
|
| Algae Oil Supplements | Active Comparator | Subjects will take 2 commercial algae oil capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algae Oil Fortified Soymilk | Other | Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Erythrocyte EPA and DHA levels | Percent EPA and DHA of total fatty acids in erythrocyte samples | 4 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Percent of days that participants consume their beverage or pill | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Vodovotz, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2023 | Apr 4, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2023 | Mar 22, 2023 | ICF_001.pdf |
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24 participants (12 men and 12 women) will be randomized to two intervention groups.
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No masking.
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| Algae Oil Capsule | Dietary Supplement | Algae oil capsules with EPA and DHA |
|
| 4 weeks |