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

• Status: Completed
• Trial end date: 2017-07-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Texas Health Science Center
• Collaborator: University of South Florida

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