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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847027
Recruitment Status : Completed
First Posted : May 6, 2013
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Meharvan Singh, University of North Texas Health Science Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Adult Stem Cell Proliferation
Interventions Drug: NutraStem
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Supplement Sugar Pill
Hide Arm/Group Description

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Period Title: Overall Study
Started 11 12
Completed 10 10
Not Completed 1 2
Arm/Group Title Active Supplement Sugar Pill Total
Hide Arm/Group Description

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  81.8%
9
  75.0%
18
  78.3%
>=65 years
2
  18.2%
3
  25.0%
5
  21.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
58.5  (6.3) 59.5  (6.1) 59.0  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
6
  54.5%
8
  66.7%
14
  60.9%
Male
5
  45.5%
4
  33.3%
9
  39.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Hispanic or Latino
1
   9.1%
1
   8.3%
2
   8.7%
Not Hispanic or Latino
10
  90.9%
11
  91.7%
21
  91.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  33.3%
4
  17.4%
White
11
 100.0%
8
  66.7%
19
  82.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11 12 23
1.Primary Outcome
Title Percentage of CD133+ Cells
Hide Description The percentage of CD133+ cells detected in blood samples
Time Frame Baseline, 2 weeks, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
subjects who completed all three visits and from whom blood draws were obtained
Arm/Group Title Active Supplement Sugar Pill
Hide Arm/Group Description:

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percent of total
Baseline (visit 1) 0.50  (0.39) 0.28  (0.15)
2 weeks (visit 2) 0.54  (0.49) 0.47  (0.54)
4 weeks (visit 3) 0.37  (0.25) 0.35  (0.27)
2.Primary Outcome
Title Percent of CD34+ Cells
Hide Description Percent of CD34+ cells detected in blood samples
Time Frame Baseline, 2 weeks, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed all three visit and from whom blood draws were successful
Arm/Group Title Active Supplement Sugar Pill
Hide Arm/Group Description:

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percent of total
Baseline (visit 1) 9.46  (6.98) 14.31  (7.4)
2 weeks (visit 2) 7.64  (8.29) 7.13  (3.97)
4 weeks (visit 3) 7.29  (6.08) 8.49  (5.95)
3.Secondary Outcome
Title Markers of Oxidative Stress
Hide Description Blood levels of C reactive protein
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed all three visits
Arm/Group Title Active Supplement Sugar Pill
Hide Arm/Group Description:

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/L
Baseline (visit 1) 1695848.62  (2084023.54) 1843643.43  (1391654.22)
4 weeks (visit 3) 873777.84  (647730.33) 1935423.36  (1096810.43)
Time Frame 4 weeks
Adverse Event Reporting Description Blood pressure is monitored in individuals while exercising (treadmill walking).
 
Arm/Group Title Active Supplement Sugar Pill
Hide Arm/Group Description

NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg).

NutraStem: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

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: Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.

All-Cause Mortality
Active Supplement Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Active Supplement Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Supplement Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      2/12 (16.67%)    
Vascular disorders     
vasovagal response   0/11 (0.00%)  0 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Meharvan Singh, PhD
Organization: University of North Texas Health Science Center
Phone: 8177355429
EMail: meharvan.singh@unthsc.edu
Layout table for additonal information
Responsible Party: Meharvan Singh, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT01847027    
Other Study ID Numbers: 2012-162
First Submitted: May 1, 2013
First Posted: May 6, 2013
Results First Submitted: December 21, 2018
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019