Evaluation of Plant-based Nutritional Products on Stem Cells

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Plant-based Nutritional Products on Stem Cells

Conditions
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Stem Cell Mobilization, Hematopoietic Stem Cell Mobilization, Stem Cell Homing

Intervention / Treatment
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* Other: Berry extract I
* Other: Berry Extract II
* Other: Berry extract blend
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study uses a randomized double-blinded placebo-controlled cross-over study design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berry extract I<br>Plant-based antioxidant-rich berry-based extract. | Other: Berry extract I<br>* Seabuckthorn berry proanthocyanidin extract 250 mg single dose<br>|
| Experimental: Berry extract II<br>Plant-based antioxidant-rich berry-based extract. | Other: Berry Extract II<br>* Seabuckthorn berry proanthocyanidin extract 500 mg single dose<br>|
| Experimental: Berry extract blend<br>Blend of plant-based antioxidant-rich berry-based extracts. | Other: Berry extract blend<br>* Seabuckthorn berry blend with other berry-based antioxidants<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change to stem cell numbers in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. | 
| Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. | 
| Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. | 
| Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. | 
| Change to numbers of circulating CD45- CD90+ stem cells in blood circulation. | Flow cytometry evaluation of stem cell phenotype. | Changes at 1 and 2 hours after consumption. |