Recruiting

Plant-based Nutrition

Sponsor:

Natural Immune Systems Inc

Code:

NCT03388073

Conditions

Stem Cell Mobilization

Hematopoietic Stem Cell Mobilization

Stem Cell Homing

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Berry extract I

Berry Extract II

Berry extract blend

Placebo

Study Details

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.

Conditions

Stem Cell Mobilization

Hematopoietic Stem Cell Mobilization

Stem Cell Homing

Study ID

NCT03388073

Start date

Jan 30, 2018

Status verified date

Feb, 2019

Completion date

Feb 2, 2020

Anticipated

Primary completion date

Dec 20, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Berry extract I

Plant-based antioxidant-rich berry-based extract.

experimental: Berry extract II

Plant-based antioxidant-rich berry-based extract.

experimental: Berry extract blend

Blend of plant-based antioxidant-rich berry-based extracts.

placebo comparator: Placebo

Interventions

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

Primary outcome measure

  • Change to stem cell numbers in blood circulation. [ Time Frame: Changes at 1 and 2 hours after consumption. ]

Central Contacts and Locations

Central contacts

Gitte Jensen

5418840112gitte@nislabs.com

Locations

Natural Immune Systems

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Gitte Jensen

541-884-0112gitte@nislabs.com

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

Mar 13, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2019-03-13.