EpiCor Clinical Study on Rapid Immune Modulating Effects

NCT05819424 | Completed

• 1 other identifier: 004-044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Surveillance

Outcome Measures

Primary Outcomes (1)

• Immune Surveillance

  Observation of changes in immune cell trafficking and status of immune cell alertness, i.e., the changes in immune cell populations and activation following administration

  At 1, 2, and 3 hours

Secondary Outcomes (1)

• Immune Communication

  At 1, 2, and 3 hours

Other Outcomes (1)

• Immune Responsiveness

  At 1, 2, and 3 hours

Study Arms (2)

Placebo intervention first and Active intervention one week later

EXPERIMENTAL

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.

Dietary Supplement: Yeast Fermentate (EpiCor)

Active intervention first and Placebo intervention one week later

EXPERIMENTAL

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.

Dietary Supplement: Yeast Fermentate (EpiCor)

Interventions

Yeast Fermentate (EpiCor) 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; Placebo intervention first and Active intervention one week later

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Cargill: lead
• Natural Immune Systems Inc: collaborator

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

Study Officials

• Gitte Jensen, PhD

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, randomized, double-blind, cross-over design.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: May 16, 2023
• Primary Completion: November 16, 2023
• Study Completion: November 17, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)