Evaluation of Plant-based Nutritional Products on Stem Cells

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.

Study Overview

• Status: Unknown
• Conditions: Stem Cell Mobilization; Hematopoietic Stem Cell Mobilization; Stem Cell Homing
• Intervention / Treatment: Other: Placebo; Other: Berry extract I; Other: Berry Extract II; Other: Berry extract blend

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • Natural Immune Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): February 2, 2020

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NIS135002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No