Exercise and NutraStem (NT-020): Effects on Stem Cells
This trial is active, not recruiting.
|Condition||adult stem cell proliferation|
|Sponsor||University of North Texas Health Science Center|
|Collaborator||University of South Florida|
|Start date||April 2013|
|End date||March 2016|
|Trial size||24 participants|
|Trial identifier||NCT01847027, 2012-162|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Increased stem cell proliferation in active supplement arm
time frame: 4 weeks
Markers of oxidative stress
time frame: 4 weeks
Male or female participants from 50 years up to 70 years old.
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
|Official title||Phase 2 Study of the Effect of a Nutritional Supplement and Exercise on Human Stem Cells|
|Principal investigator||Meharvan Singh, PhD|
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