Clinical trial NCT05819424: EpiCor Clinical Study on Rapid Immune Modulating Effects
Official title: EpiCor Clinical Study on Rapid Immune Modulating Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Surveillance
Lead sponsor: Cargill
Sponsor class: INDUSTRY
Collaborators: name: Natural Immune Systems Inc
First posted: 2023-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Placebo-controlled, randomized, double-blind, cross-over design.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults of any gender
* BMI between 18 and 30 (inclusive)
* Veins easy to see in one or both arms (to allow for multiple blood draws)
* Willing to comply with a 24-h wash-out period for vitamins and nutritional supplements
* Willing to comply with study procedures including: maintaining a consistent diet and lifestyle routine throughout the study; consistent habit of bland breakfasts on days of clinic visits; abstaining from exercising and nutritional supplements on the morning of the study visit; abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; abstaining from music, candy, bum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
* Currently in intensive athletic training (such as marathon runners)
* Currently taking antidepressant or tranquilizing medications
* Taking anti-inflammatory medications on a daily basis
* Currently experiencing intense stressful events/life changes that could negatively affect compliance
* Anything that the investigator judges may put the subject at risk or may unduly influence any of the results of the study
* An unusual sleep routine (examples: working nightshift, irregular routine with frequent late nights)
* Unwilling to maintain a constant intake of supplements over the duration of the study
* Anxiety about having blood drawn
* People of childbearing potential: pregnant, nursing, or trying to become pregnant
* Known food allergies related to ingredients in active test product or placebo

Prescription medication will be evaluated on case-by-case basis.

Primary outcomes:
measure: Immune Surveillance
timeFrame: At 1, 2, and 3 hours
Secondary outcomes:
measure: Immune Communication
timeFrame: At 1, 2, and 3 hours
Other outcomes:
measure: Immune Responsiveness
timeFrame: At 1, 2, and 3 hours
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: