Exercise and NutraStem (NT-020): Effects on Stem Cells
Condition: Adult Stem Cell Proliferation
Intervention: NutraStem; Placebo
Intervention description: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.
Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.; Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Stem cells; Aging; Increase stem cell replacement; decreased stem cell proliferation

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 NutraStem® can be found in nutrition or vitamin shops/stores.
    

Eligibility 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