Acute Effects on Stem Cell Surveillance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anthocyanin-rich berry extract, Anthocyanin-rich flower/leaf extract, Berry /leaf blend, Placebo.
- Who it may be relevant to
- Registry conditions: Stem Cell Surveillance. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.
Overview
The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.
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.
Interventions
- 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)
Primary outcome measures
- Stem cell surveillance [Time frame: Baseline, 1 hour, 2 hours after consumption]
Secondary outcome measures (1)
- Serum cytokine levels [Time frame: Baseline, 1 hour, 2 hours after consumption]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- NIS Labs — Klamath Falls
Identifiers
NCT: NCT07341178 · 211-002