This trial is active, not recruiting.

Condition adult stem cell proliferation
Treatments nutrastem, placebo
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).
nutrastem NT-020
(Placebo Comparator)
The placebo is identical in appearance to the NutraStem® supplement and contains the following ingredients in a Vegi Capsule: MCC200 DICALCIUM PHOSPHATE BROWN LAKE BLEND (SENSIENT # 09127 ) RED DYE DB-088 (COLORCON) MAGNESIUM STEARATE BLUE #1 ALUM LAKE (POWDER)
placebo Sugar pill

Primary Outcomes

Increased stem cell proliferation in active supplement arm
time frame: 4 weeks

Secondary Outcomes

Markers of oxidative stress
time frame: 4 weeks

Eligibility Criteria

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

Additional Information

Official title Phase 2 Study of the Effect of a Nutritional Supplement and Exercise on Human Stem Cells
Principal investigator Meharvan Singh, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of North Texas Health Science Center.