Stem Cell SurveillanceNCT07341178
Acute Effects on Stem Cell Surveillance
A study testing Anthocyanin-rich berry extract, Anthocyanin-rich flower/leaf extract and Berry /leaf blend 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 acute immune effects of three nutraceutical ingredients and blends to a placebo. 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?
- Anthocyanin-rich berry extract, Anthocyanin-rich flower/leaf extract and Berry /leaf blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Mar 2027
- 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);
- 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,
- Consistent habit of bland breakfasts on days of clinic visits,
Show all 9Show fewer
- 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, 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 anxiolytic, hypnotic, or anti-depressant prescription medication;
- An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
Show all 11Show fewer
- 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.
- Prescription medication will be evaluated on a case-by-case basis.
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
NIS Labs
Klamath Falls, Oregon, 97601
Gitte S. Jensen, PhD, 5418840112, gitte@nislabs.com
About this study
Official title: Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.
The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.
Read the detailed description
The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.
Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.
The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.
- Conditions
- Stem Cell Surveillance
- Being tested
- Anthocyanin-rich berry extract, Anthocyanin-rich flower/leaf extract, Berry /leaf blend, Placebo
- Keywords
- Stem cells, Flow cytometry, Surveillance, Mobilization, Homing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanin-rich berry extractDietary supplement
0.5 grams
Anthocyanin-rich flower/leaf extractDietary supplement
0.5 grams
Berry /leaf blendDietary supplement
0.5 grams
PlaceboDietary supplement
Placebo (white rice-based)
| Study group | Role | What they receive |
|---|---|---|
| Crossover Group 1, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D. Receives: Dietary Supplement: Anthocyanin-rich berry extract; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo |
| Crossover Group 2, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A. Receives: Dietary Supplement: Anthocyanin-rich berry extract; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo |
| Crossover Group 3, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B. Receives: Dietary Supplement: Anthocyanin-rich berry extract; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo |
| Crossover Group 4, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C. Receives: Dietary Supplement: Anthocyanin-rich berry extract; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem cell surveillance
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 after consumption
Secondary outcomes (1)
Serum cytokine levels
Measured: Baseline, 1 hour, 2 hours after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, acute cross-over study design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341178
- Sponsor's protocol ID
- 211-002
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.
- ClinicalTrials.gov ID
- NCT07341178
- Acronym / sponsor ID
- 211-002
- Conditions
- Stem Cell Surveillance
- Keywords
- Stem cells, Flow cytometry, Surveillance, Mobilization, Homing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Jan 2026 (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 acute immune effects of three nutraceutical ingredients and blends to a placebo.
Detailed description
The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.
Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.
The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blinded, placebo-controlled, acute cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Crossover Group 1, randomized | Experimental | Dietary Supplement: Anthocyanin-rich berry extract, Dietary Supplement: Anthocyanin-rich flower/leaf extract, Dietary Supplement: Berry /leaf blend, Dietary Supplement: PlaceboParticipants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D. |
| Crossover Group 2, randomized | Experimental | Dietary Supplement: Anthocyanin-rich berry extract, Dietary Supplement: Anthocyanin-rich flower/leaf extract, Dietary Supplement: Berry /leaf blend, Dietary Supplement: PlaceboParticipants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A. |
| Crossover Group 3, randomized | Experimental | Dietary Supplement: Anthocyanin-rich berry extract, Dietary Supplement: Anthocyanin-rich flower/leaf extract, Dietary Supplement: Berry /leaf blend, Dietary Supplement: PlaceboParticipants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B. |
| Crossover Group 4, randomized | Experimental | Dietary Supplement: Anthocyanin-rich berry extract, Dietary Supplement: Anthocyanin-rich flower/leaf extract, Dietary Supplement: Berry /leaf blend, Dietary Supplement: PlaceboParticipants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adults;
- Age 18-75 years (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 (11 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 anxiolytic, hypnotic, or anti-depressant prescription medication;
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 |
|---|---|---|
| Anthocyanin-rich berry extract0.5 grams | Dietary supplement | Crossover Group 1, randomized, Crossover Group 2, randomized, Crossover Group 3, randomized, Crossover Group 4, randomized |
| Anthocyanin-rich flower/leaf extract0.5 grams | Dietary supplement | Crossover Group 1, randomized, Crossover Group 2, randomized, Crossover Group 3, randomized, Crossover Group 4, randomized |
| Berry /leaf blend0.5 grams | Dietary supplement | Crossover Group 1, randomized, Crossover Group 2, randomized, Crossover Group 3, randomized, Crossover Group 4, randomized |
| PlaceboPlacebo (white rice-based) | Dietary supplement | Crossover Group 1, randomized, Crossover Group 2, randomized, Crossover Group 3, randomized, Crossover Group 4, randomized |
Primary outcome
Stem cell surveillance
Time frame: Baseline, 1 hour, 2 hours after consumption
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+.
1 secondary outcome
Serum cytokine levels
Time frame: Baseline, 1 hour, 2 hours after consumption
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 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Surveillance
RecruitingObservational study
A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea
Multiple Myeloma
Enrolling by invitationPhase 1/2
A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
Macular Degenerative Disease
Recruiting
Rapid Response of Stem Cells and Immune Cells for Efficacy
Stem Cell Surveillance
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 Anthocyanin-rich berry extract, Anthocyanin-rich flower/leaf extract and Berry /leaf blend 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 14 Jan 2026. 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 (541 884 0112, 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 surveillance (time frame: Baseline, 1 hour, 2 hours after consumption). 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 14 Jan 2026.