Hematopoietic Stem Cell Mobilization, Stem Cell Homing, Stem Cell Mobilization
Conditions
Brief summary
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.
Detailed description
The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.
Interventions
OTHERBerry extract I
Seabuckthorn berry proanthocyanidin extract 250 mg single dose
OTHERBerry Extract II
Seabuckthorn berry proanthocyanidin extract 500 mg single dose
OTHERBerry extract blend
Seabuckthorn berry blend with other berry-based antioxidants
OTHERPlacebo
Placebo
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Both the study participants and the research staff interacting with study participants will be blinded to the plant based extract versus placebo.
Intervention model description
The study uses a randomized double-blinded placebo-controlled cross-over study design.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults 20-75 years of age; * Body weight higher than 110 pounds; * BMI below 35;
Exclusion criteria
* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem); * Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem); * Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin); * Currently experiencing intense stressful events and life changes; * Actively depressed; * Experiencing sleep disturbances; * Working night shift; * Pregnant, nursing, or trying to become pregnant; * Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing; * Food allergies related to ingredients in test product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change to stem cell numbers in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
| Change to numbers of circulating CD45- CD90+ stem cells in blood circulation. | Changes at 1 and 2 hours after consumption. | Flow cytometry evaluation of stem cell phenotype. |
Countries
United States
Contacts
Primary ContactGitte Jensen
Outcome results
None listed