Stem Cell SurveillanceNCT07127705
Rapid Response of Stem Cells and Immune Cells for Efficacy
A study testing Chaga Mushroom, Ginseng extract and Olive extract in people with Stem Cell Surveillance, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Surveillance
- What is being tested?
- Chaga Mushroom, Ginseng extract and Olive extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults;
- Age 18 - 75 years (inclusive);
- BMI between 18.0 and 34.9 (inclusive);
- Veins easy to see in one or both arms (to allow for the multiple blood draws);
- Willing to comply with study procedures, including:
- Maintaining a consistent diet and lifestyle routine throughout the study,
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- Consistent habit of bland breakfasts on days of clinic visits,
- Abstaining from exercising and nutritional supplements on the morning of a 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, gum, computer/cell phone use (airplane mode is allowed), 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);
- Taking anti-inflammatory medications on a daily basis;
- Currently experiencing intense stressful events/ life changes;
- Currently in intensive athletic training (such as marathon runners);
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
- An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
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- Unwilling to maintain a constant intake of supplements over the duration of the study;
- Anxiety about having blood drawn;
- Pregnant, nursing, or trying to become pregnant;
- Known food allergies related to ingredients in active test product or placebo.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Cruickshank contact
United States1 site, 1 recruiting
- Recruiting
NIS Labs
Klamath Falls, Oregon, 97601
Gitte S. Jensen, PhD, 541-884-0112, Gitte@nislabs.com
About this study
Official title: Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial
The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.
Read the detailed description
This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.
Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.
- Conditions
- Stem Cell Surveillance
- Being tested
- Placebo, Chaga Mushroom, Ginseng extract, Olive extract, Potassium Hydrogen Glucarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
2 capsules
Chaga MushroomDietary supplement
2 capsules
Ginseng extractDietary supplement
2 capsules
Olive extractDietary supplement
2 capsules
Potassium Hydrogen GlucarateDietary supplement
2 capsules
| Study group | Role | What they receive |
|---|---|---|
| Crossover group 1, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E. Receives: Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate |
| Crossover group 2, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D. Receives: Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate |
| Crossover group 3, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B. Receives: Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate |
| Crossover group 4, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E. Receives: Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem cell trafficking
Changes to the number of stem cells in the blood circulation (number of cells per mL blood).
Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.
Measured: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Secondary outcomes (2)
Mitochondrial volume per cell
Mitochondrial volume per cell under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.
Measured: Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug
Mitochondrial membrane potential per cell
Cellular energy production under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cells, using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.
Measured: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start21 May 2025
- Primary completion27 Aug 2025 (estimated)
- Study completion3 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, randomized, double-blinded, cross-over study design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Food Sciences Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127705
- Sponsor's protocol ID
- 186-006
- Status last verified
- Aug 2025
- First submitted
- 19 May 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT07127705
- Acronym / sponsor ID
- 186-006
- Conditions
- Stem Cell Surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Collaborators
- Applied Food Sciences Inc.
- Study start
- 21 May 2025 (actual)
- Primary completion
- 27 Aug 2025 (estimated)
- Study completion
- 3 Oct 2025 (estimated)
- First posted
- 17 Aug 2025 (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.
The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.
Detailed description
This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.
Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Placebo-controlled, randomized, double-blinded, cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Crossover group 1, randomized | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Chaga Mushroom, Dietary Supplement: Ginseng extract, Dietary Supplement: Olive extract, Dietary Supplement: Potassium Hydrogen GlucarateCrossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E. |
| Crossover group 2, randomized | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Chaga Mushroom, Dietary Supplement: Ginseng extract, Dietary Supplement: Olive extract, Dietary Supplement: Potassium Hydrogen GlucarateCrossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D. |
| Crossover group 3, randomized | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Chaga Mushroom, Dietary Supplement: Ginseng extract, Dietary Supplement: Olive extract, Dietary Supplement: Potassium Hydrogen GlucarateCrossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B. |
| Crossover group 4, randomized | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Chaga Mushroom, Dietary Supplement: Ginseng extract, Dietary Supplement: Olive extract, Dietary Supplement: Potassium Hydrogen GlucarateCrossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy adults;
- Age 18 - 75 years (inclusive);
- BMI between 18.0 and 34.9 (inclusive);
- Veins easy to see in one or both arms (to allow for the multiple blood draws);
- Willing to comply with study procedures, including:
Key exclusion criteria (10 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);
- Taking anti-inflammatory medications on a daily basis;
- Currently experiencing intense stressful events/ life changes;
- Currently in intensive athletic training (such as marathon runners);
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
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 |
|---|---|---|
| Placebo2 capsules | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized, Crossover group 4, randomized |
| Chaga Mushroom2 capsules | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized, Crossover group 4, randomized |
| Ginseng extract2 capsules | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized, Crossover group 4, randomized |
| Olive extract2 capsules | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized, Crossover group 4, randomized |
| Potassium Hydrogen Glucarate2 capsules | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized, Crossover group 4, randomized |
Primary outcome
Stem cell trafficking
Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Changes to the number of stem cells in the blood circulation (number of cells per mL blood). Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.
2 secondary outcomes
Mitochondrial volume per cell
Time frame: Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug
Mitochondrial membrane potential per cell
Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- 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.
Alex Cruickshank contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chaga Mushroom, Ginseng extract and Olive extract in people with Stem Cell Surveillance, run by Natural Immune Systems Inc 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gitte S. Jensen, PhD (5418820112, Gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stem cell trafficking (time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.