Trials / Completed
CompletedNCT05819424
EpiCor Clinical Study on Rapid Immune Modulating Effects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Cargill · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Yeast Fermentate (EpiCor) | Dietary Supplement: Yeast Fermentate (EpiCor): Postbiotic whole food fermentate made using yeast. Composed of proteins, polyphenols, vitamins, minerals, amino acids, polysaccharides, fibre, and other nutrients. Placebo: Substance with no therapeutic value to facilitate blinding |
Timeline
- Start date
- 2023-05-16
- Primary completion
- 2023-11-16
- Completion
- 2023-11-17
- First posted
- 2023-04-19
- Last updated
- 2024-01-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05819424. Inclusion in this directory is not an endorsement.