Status:
COMPLETED
Exercise and NutraStem (NT-020): Effects on Stem Cells
Lead Sponsor:
University of North Texas Health Science Center
Collaborating Sponsors:
University of South Florida
Conditions:
Adult Stem Cell Proliferation
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
Brief Summary
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 NutraS...
Detailed Description
A randomized double blinded placebo controlled trial of a nutraceutical preparation. Up to 60 men and women between the ages of 50 and 70, and generally healthy will participate in this study. . Up to...
Eligibility Criteria
Inclusion
- Healthy men and women
- Age 50 to 70 years old
- Ability to walk on a treadmill for 15 minutes.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01847027
Start Date
April 1 2013
End Date
July 17 2017
Last Update
May 29 2019
Active Locations (1)
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1
University of North Texas Health Science Center - Center for Biohealth
Fort Worth, Texas, United States, 76107