Rapid Response of Stem Cells and Immune Cells for Efficacy
NCT ID: NCT07127705
Last Updated: 2025-08-17
Study Results
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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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-05-21
2025-10-03
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
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.
Placebo
2 capsules
Chaga Mushroom
2 capsules
Ginseng extract
2 capsules
Olive extract
2 capsules
Potassium Hydrogen Glucarate
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.
Placebo
2 capsules
Chaga Mushroom
2 capsules
Ginseng extract
2 capsules
Olive extract
2 capsules
Potassium Hydrogen Glucarate
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.
Placebo
2 capsules
Chaga Mushroom
2 capsules
Ginseng extract
2 capsules
Olive extract
2 capsules
Potassium Hydrogen Glucarate
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.
Placebo
2 capsules
Chaga Mushroom
2 capsules
Ginseng extract
2 capsules
Olive extract
2 capsules
Potassium Hydrogen Glucarate
2 capsules
Interventions
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Placebo
2 capsules
Chaga Mushroom
2 capsules
Ginseng extract
2 capsules
Olive extract
2 capsules
Potassium Hydrogen Glucarate
2 capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Applied Food Sciences
UNKNOWN
Natural Immune Systems Inc
OTHER
Responsible Party
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Locations
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NIS Labs
Klamath Falls, Oregon, United States
Countries
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Central Contacts
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Alex Cruickshank
Role: CONTACT
Facility Contacts
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Other Identifiers
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186-006
Identifier Type: -
Identifier Source: org_study_id
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