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Clinical verification study evaluating the effects of a nutraceutical product. This study involves thirty participants composed of healthy adults, who will be taking either a placebo or nutraceutical supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the nutraceutical on immune function compared to a placebo.
Clinical study comparing the acute immune effect of a nutraceutical product and a placebo. The nutraceutical supplement is a postbiotic whole food fermentate produced using yeast. 30 subjects will participate in a placebo-controlled, double-blind, randomized, cross-over design, wherein they will be taking a placebo, or nutraceutical product, each separated by a 1-week washout period to evaluate effects within 3 hours of consumption. Blood samples will be taken 1 hour after participants arrive, then the dose is administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration. A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, and cytokine profiles. Ex vivo immune challenges will be used to determine the direct impacts on immune cells.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
NIS Labs
Klamath Falls, Oregon, United States
Start Date
May 16, 2023
Primary Completion Date
November 16, 2023
Completion Date
November 17, 2023
Last Updated
January 25, 2024
30
ACTUAL participants
Yeast Fermentate (EpiCor)
DIETARY_SUPPLEMENT
Lead Sponsor
Cargill
Collaborators
Data Source & Attribution
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