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Evaluation of Plant-based Nutritional Products on Stem Cells

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ClinicalTrials.gov Identifier: NCT03388073
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stem Cell Mobilization Hematopoietic Stem Cell Mobilization Stem Cell Homing Other: Berry extract I Other: Berry Extract II Other: Berry extract blend Other: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study uses a randomized double-blinded placebo-controlled cross-over study design.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Both the study participants and the research staff interacting with study participants will be blinded to the plant based extract versus placebo.
Primary Purpose: Basic Science
Official Title: Evaluation of Plant-based Nutritional Products on Stem Cells
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : May 31, 2018

Arm Intervention/treatment
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

Placebo Comparator: Placebo Other: Placebo
Placebo




Primary Outcome Measures :
  1. Change to stem cell numbers in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.


Secondary Outcome Measures :
  1. Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.

  2. Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.

  3. Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.

  4. Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.

  5. Change to numbers of circulating CD45- CD90+ stem cells in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]
    Flow cytometry evaluation of stem cell phenotype.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388073


Contacts
Contact: Gitte Jensen 5418840112 gitte@nislabs.com

Locations
United States, Oregon
Natural Immune Systems Recruiting
Klamath Falls, Oregon, United States, 97601
Contact: Gitte Jensen    541-884-0112    gitte@nislabs.com   
Sponsors and Collaborators
Natural Immune Systems Inc
Investigators
Study Director: Gitte Jensen NIS Labs

Responsible Party: Natural Immune Systems Inc
ClinicalTrials.gov Identifier: NCT03388073     History of Changes
Other Study ID Numbers: NIS135002
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antioxidants
Proanthocyanidin
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents