Immune SurveillanceNCT05819424
EpiCor Clinical Study on Rapid Immune Modulating Effects
A study testing Yeast Fermentate (EpiCor) in people with Immune Surveillance, run by Cargill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Surveillance
- What is being tested?
- Yeast Fermentate (EpiCor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Yeast Fermentate (EpiCor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Yeast Fermentate (EpiCor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1, 2, and 3 hours
Secondary outcomes (1)
Immune Communication
Serum cytokine levels as assessed by changes in cytokine levels individually versus placebo
Measured: At 1, 2, and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start16 May 2023
- Primary completion16 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune SurveillanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, randomized, double-blind, cross-over design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Natural Immune Systems Inc
- Responsible party
- Sponsor
- Investigators
- Gitte Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819424
- Sponsor's protocol ID
- 004-044
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen GS, Cruickshank DD, Grinage EAF, Cruickshank D, Sanchez K, Garcia-Campayo V, Paton ND, Green JB. A yeast-derived postbiotic fermentate rapidly modulates inflammatory cytokines and immune surveillance markers in healthy adults: a randomized double-blind placebo-controlled cross-over trial. Front Nutr. 2026 Aug 6;13:1897550. doi: 10.3389/fnut.2026.1897550. eCollection 2026.
PubMed 42625679
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiCor Clinical Study on Rapid Immune Modulating Effects
- ClinicalTrials.gov ID
- NCT05819424
- Acronym / sponsor ID
- 004-044
- Conditions
- Immune Surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- Natural Immune Systems Inc
- Study start
- 16 May 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled, randomized, double-blind, cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Placebo intervention first and Active intervention one week later | Experimental | Dietary Supplement: Yeast Fermentate (EpiCor)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. |
| Active intervention first and Placebo intervention one week later | Experimental | Dietary Supplement: Yeast Fermentate (EpiCor)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Active intervention first and Placebo intervention one week later, Placebo intervention first and Active intervention one week later |
Primary outcome
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
1 secondary outcome
Immune Communication
Time frame: At 1, 2, and 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 42625679Jensen GS, Cruickshank DD, Grinage EAF, Cruickshank D, Sanchez K, Garcia-Campayo V, Paton ND, Green JB. A yeast-derived postbiotic fermentate rapidly modulates inflammatory cytokines and immune surveillance markers in healthy adults: a randomized double-blind placebo-controlled cross-over trial. Front Nutr. 2026 Aug 6;13:1897550. doi: 10.3389/fnut.2026.1897550. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yeast Fermentate (EpiCor) in people with Immune Surveillance, run by Cargill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Surveillance (time frame: At 1, 2, and 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.