Exercise and NutraStem (NT-020): Effects on Stem Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of North Texas Health Science Center
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Meharvan Singh, University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT01847027
First received: May 1, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to see if an investigational supplement called NutraStem® will increase the amount of stem cells in human blood at rest and after exercise. The ingredients found in NutraStem® can be found in nutrition or vitamin shops/stores.


Condition Intervention Phase
Adult Stem Cell Proliferation
Drug: NutraStem
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Effect of a Nutritional Supplement and Exercise on Human Stem Cells

Resource links provided by NLM:


Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:
  • Increased stem cell proliferation in active supplement arm [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Markers of oxidative stress [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active supplement
NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).
Drug: NutraStem
Other Name: NT-020
Placebo Comparator: Sugar pill

The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule:

MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)

Drug: Placebo
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women
  • Age 50 to 70 years old
  • Ability to walk on a treadmill for 15 minutes.

Exclusion Criteria:

  • Age less than 50 or greater than 70 years of age.
  • A history of difficult veins/difficulty obtaining blood samples
  • Unwilling to follow the procedures of the trial
  • Participated in more than 2 sessions per week of strenuous exercise in the last month
  • Unable to tolerate the ingredients in NutraStem® or placebo, or have food allergies
  • Intentionally lost or gained 10 or more pounds of body weight in the last 3 months
  • Acute illness
  • Severe co-morbid disease
  • Use of any prescription or non-prescription products for antioxidant regimen or stem cell supplement within the past 4 weeks
  • Diabetic
  • Uncontrolled hypertension
  • Recent cardiovascular event (past 36 months), or a family history of sudden death or heart attacks before the age of 55
  • Body Mass Index (BMI) of less than 20 or greater than 35 m/kg2;
  • Participated in a clinical trial in the past 4 weeks
  • Take methadone, insulin, anticoagulants (blood thinners), MAO's or similar medications
  • Anticipate the need for surgery of any type during the entire study;
  • Plan to donate blood or blood products during the study or for thirty (30) days following the study
  • Active peptic ulcer disease or reliable history of gastrointestinal bleeding within the past five (5) years
  • Recurrent or a history of intestinal disorders that may interfere with the absorption of the product
  • Any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847027

Contacts
Contact: Kim Brown, RN 817-735-2694 kim.brown@unthsc.edu
Contact: Meharvan Singh, PhD 817-735-5429 meharvan.singh@unthsc.edu

Locations
United States, Texas
University of North Texas Health Science Center - Center for Biohealth Recruiting
Fort Worth, Texas, United States, 76107
Contact: Kim Brown, RN    817-735-2694    kim.brown@unthsc.edu   
Contact: Meharvan Singh, PhD    817-735-5429    meharvan.singh@unthsc.edu   
Principal Investigator: Meharvan Singh, PhD         
Sponsors and Collaborators
University of North Texas Health Science Center
University of South Florida
Investigators
Principal Investigator: Meharvan Singh, PhD University of North Texas Health Science Center
  More Information

No publications provided

Responsible Party: Meharvan Singh, Chairman and Professor, Department of Pharmacology and Neuroscience, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT01847027     History of Changes
Other Study ID Numbers: 2012-162
Study First Received: May 1, 2013
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Texas Health Science Center:
Healthy
Stem cells
Aging
Increase stem cell replacement
decreased stem cell proliferation

ClinicalTrials.gov processed this record on September 16, 2014