Acute Effects on Stem Cell Surveillance

January 6, 2026 updated by: Natural Immune Systems Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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,
    • 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.

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);
  • 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);
  • 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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crossover Group 1, randomized
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.
Dietary supplement: Anthocyanin-rich berry extract
0.5 grams
Dietary supplement: Anthocyanin-rich flower/leaf extract
0.5 grams
Dietary supplement: Berry /leaf blend
0.5 grams
Dietary supplement: Placebo
Placebo (white rice-based)
Experimental: Crossover Group 2, randomized
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.
Dietary supplement: Anthocyanin-rich berry extract
0.5 grams
Dietary supplement: Anthocyanin-rich flower/leaf extract
0.5 grams
Dietary supplement: Berry /leaf blend
0.5 grams
Dietary supplement: Placebo
Placebo (white rice-based)
Experimental: Crossover Group 3, randomized
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.
Dietary supplement: Anthocyanin-rich berry extract
0.5 grams
Dietary supplement: Anthocyanin-rich flower/leaf extract
0.5 grams
Dietary supplement: Berry /leaf blend
0.5 grams
Dietary supplement: Placebo
Placebo (white rice-based)
Experimental: Crossover Group 4, randomized
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.
Dietary supplement: Anthocyanin-rich berry extract
0.5 grams
Dietary supplement: Anthocyanin-rich flower/leaf extract
0.5 grams
Dietary supplement: Berry /leaf blend
0.5 grams
Dietary supplement: Placebo
Placebo (white rice-based)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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+.
Baseline, 1 hour, 2 hours after consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum cytokine levels
Time Frame: Baseline, 1 hour, 2 hours after consumption
Baseline, 1 hour, 2 hours after consumption

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Natural Immune Systems Inc

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 211-002

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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