Evaluation of Plant-based Nutritional Products on Stem Cells

Hematopoietic Stem Cell Mobilization Clinical Trial

Official title:

Evaluation of Plant-based Nutritional Products on Stem Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388073
• Other study ID #: NIS135002
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: February 2, 2020

Study information

• Verified date: February 2019
• Source: Natural Immune Systems Inc
• Contact: Gitte Jensen
• Phone: 5418840112
• Email: gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 2, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Mobilization
• Stem Cell Homing
• Stem Cell Mobilization

Intervention

Other:
• Berry extract I
Seabuckthorn berry proanthocyanidin extract 250 mg single dose
• Berry Extract II
Seabuckthorn berry proanthocyanidin extract 500 mg single dose
• Berry extract blend
Seabuckthorn berry blend with other berry-based antioxidants
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Natural Immune Systems	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change to stem cell numbers in blood circulation.	Flow cytometry evaluation of stem cell phenotype.	Changes at 1 and 2 hours after consumption.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.