Acute Effects on Stem Cell Surveillance

NCT ID: NCT07341178

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-03-31

Brief Summary

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The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.

Detailed Description

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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

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Stem Cell Surveillance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blinded, placebo-controlled, acute cross-over study design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Anthocyanin-rich berry extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Anthocyanin-rich flower/leaf extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Berry /leaf blend

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (white rice-based)

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.

Group Type EXPERIMENTAL

Anthocyanin-rich berry extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Anthocyanin-rich flower/leaf extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Berry /leaf blend

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (white rice-based)

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.

Group Type EXPERIMENTAL

Anthocyanin-rich berry extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Anthocyanin-rich flower/leaf extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Berry /leaf blend

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (white rice-based)

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.

Group Type EXPERIMENTAL

Anthocyanin-rich berry extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Anthocyanin-rich flower/leaf extract

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Berry /leaf blend

Intervention Type DIETARY_SUPPLEMENT

0.5 grams

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (white rice-based)

Interventions

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Anthocyanin-rich berry extract

0.5 grams

Intervention Type DIETARY_SUPPLEMENT

Anthocyanin-rich flower/leaf extract

0.5 grams

Intervention Type DIETARY_SUPPLEMENT

Berry /leaf blend

0.5 grams

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (white rice-based)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Immune Systems Inc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NIS Labs

Klamath Falls, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Gitte S Jensen, PhD

Role: CONTACT

541 884 0112

Alex Cruickshank

Role: CONTACT

Facility Contacts

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Gitte S. Jensen, PhD

Role: primary

5418840112

Other Identifiers

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211-002

Identifier Type: -

Identifier Source: org_study_id

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