EpiCor Clinical Study on Rapid Immune Modulating Effects

Completed · Not applicable · Has a placebo group

Conditions studied: Immune Surveillance

In brief

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.

Key facts

Study ID

NCT05819424

Run by

Cargill

People needed

30

Starts

2023-05-16

Expected to finish

2023-11-17

Last updated by the study team

2024-01-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NIS Labs — Klamath Falls, Oregon, United States

Full record on ClinicalTrials.gov

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