Evaluation of Plant-based Nutritional Products on Stem Cells

Not Applicable

• Conditions: Stem Cell Mobilization; Stem Cell Homing; Hematopoietic Stem Cell Mobilization
• Interventions: Other: Berry Extract II; Other: Berry extract blend; Other: Berry extract I; Other: Placebo

• Registration Number: NCT03388073
• Lead Sponsor: Natural Immune Systems Inc

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.

Study Timeline

• Study First Submitted: 2017-12-23
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-02
• Study Start: 2018-01-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-12-20
• Study Completion: 2020-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Berry extract II	Berry Extract II	Plant-based antioxidant-rich berry-based extract.
Berry extract blend	Berry extract blend	Blend of plant-based antioxidant-rich berry-based extracts.
Berry extract I	Berry extract I	Plant-based antioxidant-rich berry-based extract.
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change to stem cell numbers in blood circulation.	Changes at 1 and 2 hours after consumption.	Flow cytometry evaluation of stem cell phenotype.

Secondary Outcome Measures

Name	Time	Method
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 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+ 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- CD90+ stem cells in blood circulation.	Changes at 1 and 2 hours after consumption.	Flow cytometry evaluation of stem cell phenotype.

Trial Locations

Locations (1)

Natural Immune Systems; 🇺🇸 Klamath Falls, Oregon, United States