EpiCor Clinical Study on Rapid Immune Modulating Effects

January 24, 2024 updated by: Cargill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • NIS Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Surveillance
Time Frame: At 1, 2, and 3 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Communication
Time Frame: At 1, 2, and 3 hours
Serum cytokine levels as assessed by changes in cytokine levels individually versus placebo
At 1, 2, and 3 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Responsiveness
Time Frame: At 1, 2, and 3 hours
Ex vivo immune challenges, observing the capabilities of anti-bacterial and anti-viral defenses. Additionally, mucosal immune protection as determined by salivary IgA, defensins, and transferrin changes.
At 1, 2, and 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cargill

Collaborators

Natural Immune Systems Inc

Investigators

  • Principal Investigator: Gitte Jensen, PhD, NIS Labs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 004-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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