EpiCor Clinical Study on Rapid Immune Modulating Effects

NCT ID: NCT05819424

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2023-11-17

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.

Conditions

Immune Surveillance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo intervention first and Active intervention one week later

Participants will be consuming a placebo on a clinic day at least one week prior to a clinic day where they will consume the active intervention.

Group Type: EXPERIMENTAL

Yeast Fermentate (EpiCor)

Intervention Type: DIETARY_SUPPLEMENT

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

Active intervention first and Placebo intervention one week later

Participants will be consuming active intervention on a clinic day at least 1 week prior to a clinic day where they will consume the placebo.

Group Type: EXPERIMENTAL

Yeast Fermentate (EpiCor)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Immune Systems Inc

OTHER

Sponsor Role: collaborator

Cargill

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gitte Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Locations

NIS Labs

Klamath Falls, Oregon, United States

Countries

United States

Other Identifiers

004-044

Identifier Type: -

Identifier Source: org_study_id