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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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2026-01-31
2027-03-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
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.
Anthocyanin-rich berry extract
0.5 grams
Anthocyanin-rich flower/leaf extract
0.5 grams
Berry /leaf blend
0.5 grams
Placebo
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.
Anthocyanin-rich berry extract
0.5 grams
Anthocyanin-rich flower/leaf extract
0.5 grams
Berry /leaf blend
0.5 grams
Placebo
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.
Anthocyanin-rich berry extract
0.5 grams
Anthocyanin-rich flower/leaf extract
0.5 grams
Berry /leaf blend
0.5 grams
Placebo
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.
Anthocyanin-rich berry extract
0.5 grams
Anthocyanin-rich flower/leaf extract
0.5 grams
Berry /leaf blend
0.5 grams
Placebo
Placebo (white rice-based)
Interventions
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Anthocyanin-rich berry extract
0.5 grams
Anthocyanin-rich flower/leaf extract
0.5 grams
Berry /leaf blend
0.5 grams
Placebo
Placebo (white rice-based)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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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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Facility Contacts
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Other Identifiers
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211-002
Identifier Type: -
Identifier Source: org_study_id
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