Stem Cell Surveillance
Conditions
Keywords
Stem cells, Flow cytometry, Surveillance, Mobilization, Homing
Brief summary
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_SUPPLEMENTAnthocyanin-rich berry extract
0.5 grams
DIETARY_SUPPLEMENTAnthocyanin-rich flower/leaf extract
0.5 grams
DIETARY_SUPPLEMENTBerry /leaf blend
0.5 grams
DIETARY_SUPPLEMENTPlacebo
Placebo (white rice-based)
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blinded, placebo-controlled, acute cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stem cell surveillance | Baseline, 1 hour, 2 hours after consumption | Changes to the number of stem cells in the blood circulation (number of cells per mL blood). Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+. |
Secondary
| Measure | Time frame |
|---|---|
| Serum cytokine levels | Baseline, 1 hour, 2 hours after consumption |
Countries
United States
Contacts
Primary ContactGitte S Jensen, PhD
Backup ContactAlex Cruickshank
Outcome results
None listed