Clinical trial NCT03388073: Evaluation of Plant-based Nutritional Products on Stem Cells
Official title: Evaluation of Plant-based Nutritional Products on Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stem Cell Mobilization
Hematopoietic Stem Cell Mobilization
Stem Cell Homing
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study uses a randomized double-blinded placebo-controlled cross-over study design.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change to stem cell numbers in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
Secondary outcomes:
measure: Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
measure: Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
measure: Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
measure: Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
measure: Change to numbers of circulating CD45- CD90+ stem cells in blood circulation.
timeFrame: Changes at 1 and 2 hours after consumption.
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: Natural Immune Systems
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen
role: STUDY_DIRECTOR
References: