Exercise and NutraStem (NT-020): Effects on Stem Cells
Exercise and NutraStem (NT-020): Effects on Stem Cells
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.
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 30 participants will receive the nutritional supplement and up to 30 will
 receive placebo.

 Potential participants will be screened by telephone and have the study explained to them in
 detail. If they qualify and choose to participate they will come in for the first of three
 visits. Informed consent will be obtained and demographic information collected. Information
 requested on the demographic form includes ethnicity, income, education, marital status,
 smoking and alcohol use, and exercise habits. Next they will have blood pressure checked and
 if not within parameters they will be dropped from the study and informed that they need to
 follow up the abnormal result with their health care provider. Those that pass these
 screening tests will have 15 to 25 cc's of peripheral blood (serum) collected by the study
 coordinator via venipuncture while at rest. They will then stretch for 2 minutes (60 seconds
 marching in place followed by 10 toe touches) followed by accelerating treadmill walking
 exercise. The exercise intervention will consist of a 15 minute period of walking on a
 treadmill. The treadmill will not be inclined during the intervention. The participants
 target heart rate will be determined by deducting their age from 220. They will start walking
 on the treadmill at a speed of 1.7 mph and the speed will be titrated as indicated to keep
 their heart rate at 50 to 90% of target. Heart rate will be monitored via the pulse oximetry
 feature of the Welch Allyn vital signs monitor. Blood pressure will be measured every 3
 minutes during the exercise intervention and until they have returned to baseline (within 10
 points) following cessation of the exercise protocol. The test will be stopped for any
 participant complaint of chest pain, excess fatigue, difficulty breathing, a blood pressure
 reading of more than 180/94, or a participant request. If symptoms increase or do not
 completely resolve with 15 minutes of rest the study coordinator will call 911 (through
 campus police) to activate the EMS response. If symptoms resolve completely within 15 minutes
 participants will be withdrawn from the study and advised to follow up with their health care
 provider. Any participant unable to complete the exercise intervention for any reason will be
 withdrawn from the study.

 Five to fifteen minutes after the exercise intervention has been completed blood will again
 be collected in exactly the same manner as the resting sample. Participants will then receive
 a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every
 morning and evening before meals for the next 2 weeks. If the participant is unable to
 complete any portion of the visit activities at any visit they will be withdrawn from the
 study due to their inability to complete the study. All visit activities will be recorded in
 detail on the visit session record.

 The second visit will occur 2 weeks later and include a blood pressure check, an at rest
 blood draw, the exercise intervention, and then a repeat blood draw five to fifteen minutes
 after completion of the intervention. Participants will then receive a 2 week supply of
 either NutraStem or placebo and will be advised to take one tablet every morning and evening
 before meals for the next 2 weeks. I Participants will be advised to bring their empty pill
 containers to their next session so we can confirm they are taking the supplement as
 required. If the blood pressure is outside of the specified range they will be dropped from
 the study and no blood collection or study intervention will take place.

 The third visit will be the same as the second visit.
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