Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802797
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-03-22
Brief Title:
Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vegetarianismveganism 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 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None