Evaluation of Plant-based Nutritional Products on Stem Cells | NCT03388073

Studies
Evaluation of Plant-based Nutritional Products on Stem Cells

NCT03388073

Sponsor

Natural Immune Systems Inc

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Stem Cell Mobilization
Hematopoietic Stem Cell Mobilization
Stem Cell Homing

Interventions

Berry extract I
Berry Extract II
Berry extract blend
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2018Actual

Primary Completion Date

Dec 20, 2019Estimated

Completion Date

Feb 2, 2020Estimated

First Submitted Date

Dec 23, 2017

First Submission Date that Met QC Criteria

Dec 29, 2017

First Posted Date

Jan 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Berry extract I	Other	Seabuckthorn berry proanthocyanidin extract 250 mg single dose	Berry extract I

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gitte Jensen	Contact	5418840112		gitte@nislabs.com

Overall Officials

Name	Affiliation	Role
Gitte Jensen	NIS Labs	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Natural Immune Systems	Recruiting	Klamath Falls	Oregon	97601	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided