Rapid Response of Stem Cells and Immune Cells for Efficacy

NCT ID: NCT07127705

Last Updated: 2025-08-17

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

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2025-10-03

Brief Summary

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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

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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

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Stem Cell Surveillance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Placebo-controlled, randomized, double-blinded, cross-over study design.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Crossover group 1, randomized

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Chaga Mushroom

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Ginseng extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Olive extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Potassium Hydrogen Glucarate

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Crossover group 2, randomized

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Chaga Mushroom

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Ginseng extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Olive extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Potassium Hydrogen Glucarate

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Crossover group 3, randomized

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Chaga Mushroom

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Ginseng extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Olive extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Potassium Hydrogen Glucarate

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Crossover group 4, randomized

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Chaga Mushroom

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Ginseng extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Olive extract

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Potassium Hydrogen Glucarate

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Interventions

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Placebo

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Chaga Mushroom

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Ginseng extract

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Olive extract

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Potassium Hydrogen Glucarate

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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,
* 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.

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 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);
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Food Sciences

UNKNOWN

Sponsor Role collaborator

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 RECRUITING

Countries

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United States

Central Contacts

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Gitte S. Jensen, PhD

Role: CONTACT

5418820112

Alex Cruickshank

Role: CONTACT

Facility Contacts

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Gitte S. Jensen, PhD

Role: primary

541-884-0112

Other Identifiers

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186-006

Identifier Type: -

Identifier Source: org_study_id

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