Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
NCT Number: NCT05802797
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Early Phase 1
Columbus, Ohio, 43210, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA
Algae oil capsules with EPA and DHA
Time frame: 4 weeks
Percent EPA and DHA of total fatty acids in erythrocyte samples
Time frame: 4 weeks
Percent EPA and DHA of total fatty acids in plasma samples
Time frame: 4 weeks
Percent EPA and DHA of total fatty acids in PBMC samples
Time frame: 4 weeks
Percent of days that participants consume their beverage or pill
Ohio State University Comprehensive Cancer Center
Other
Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04079855
Healthy Diet
Beltsville, Maryland, United States
View Trial DetailsNCT06698094
Behavior, Healthy Diet
Västerås, Västmanland County, Sweden
View Trial DetailsNCT04329962
Healthy Diet, Nutrition Aspect of Cancer
Columbus, Ohio, United States
View Trial DetailsNCT06648226
Behavior, Behavior, Animal
Palo Alto, California, United States
View Trial Details