Phase 2
Completed N=23
Exercise and NutraStem (NT-020): Effects on Stem Cells
Adult Stem Cell Proliferation
Source: ClinicalTrials.gov NCT01847027 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of CD133+ Cells — 0.50; 0.28; 0.54; 0.47 percent of total
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of CD133+ Cells |
0.50; 0.28; 0.54; 0.47; 0.37; 0.35 | — |
| PRIMARY Percent of CD34+ Cells |
9.46; 14.31; 7.64; 7.13; 7.29; 8.49 | — |
| SECONDARY Markers of Oxidative Stress |
1695848.62; 1843643.43; 873777.84; 1935423.36 | — |
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
Data sourced from ClinicalTrials.gov (NCT01847027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.