NCT03388073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

December 23, 2017

Last Update Submit

March 11, 2019

Conditions

Stem Cell MobilizationHematopoietic Stem Cell MobilizationStem Cell Homing

Outcome Measures

Primary Outcomes (1)

  • Change to stem cell numbers in blood circulation.

    Flow cytometry evaluation of stem cell phenotype.

    Changes at 1 and 2 hours after consumption.

Secondary Outcomes (5)

  • Change to numbers of circulating CD45dim CD34+ stem cells in blood circulation.

    Changes at 1 and 2 hours after consumption.

  • Change to numbers of circulating CD45dim CD34+ CD309- stem cells in blood circulation.

    Changes at 1 and 2 hours after consumption.

  • Change to numbers of circulating CD45dim CD34+ CD309+ stem cells in blood circulation.

    Changes at 1 and 2 hours after consumption.

  • Change to numbers of circulating CD45- CD31+ CD309+ stem cells in blood circulation.

    Changes at 1 and 2 hours after consumption.

  • Change to numbers of circulating CD45- CD90+ stem cells in blood circulation.

    Changes at 1 and 2 hours after consumption.

Study Arms (4)

Berry extract I

EXPERIMENTAL

Plant-based antioxidant-rich berry-based extract.

Other: Berry extract I

Berry extract II

EXPERIMENTAL

Plant-based antioxidant-rich berry-based extract.

Other: Berry Extract II

Berry extract blend

EXPERIMENTAL

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

Other: Berry extract blend

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Berry extract IOTHER

Seabuckthorn berry proanthocyanidin extract 250 mg single dose

Berry extract I
Berry Extract IIOTHER

Seabuckthorn berry proanthocyanidin extract 500 mg single dose

Berry extract II
Berry extract blendOTHER

Seabuckthorn berry blend with other berry-based antioxidants

Berry extract blend
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults 20-75 years of age;
  • Body weight higher than 110 pounds;
  • BMI below 35;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natural Immune Systems

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Officials

  • Gitte Jensen

    NIS Labs

    STUDY DIRECTOR

Central Study Contacts

Gitte Jensen

CONTACT

5418840112gitte@nislabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Both the study participants and the research staff interacting with study participants will be blinded to the plant based extract versus placebo.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The study uses a randomized double-blinded placebo-controlled cross-over study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 2, 2018

Study Start

January 30, 2018

Primary Completion

December 20, 2019

Study Completion

February 2, 2020

Last Updated

March 13, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)