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

• 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: University of North Texas Health Science Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Active Supplement	Sugar Pill
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

Baseline Characteristics

Arm/Group Title		Active Supplement	Sugar Pill	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Percentage of CD133+ Cells
Description	The percentage of CD133+ cells detected in blood samples
Time Frame	Baseline, 2 weeks, 4 weeks

Outcome Measure Data

Analysis Population Description

subjects who completed all three visits and from whom blood draws were obtained

Arm/Group Title	Active Supplement	Sugar Pill
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
Description	Percent of CD34+ cells detected in blood samples
Time Frame	Baseline, 2 weeks, 4 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed all three visit and from whom blood draws were successful

Arm/Group Title	Active Supplement	Sugar Pill
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
Description	Blood levels of C reactive protein
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Subjects who completed all three visits

Arm/Group Title	Active Supplement	Sugar Pill
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)

Adverse Events

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
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%)
Serious Adverse Events
	Active Supplement		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0.00%)		0/12 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Meharvan Singh, PhD
• Organization: University of North Texas Health Science Center
• Phone: 8177355429
• EMail: meharvan.singh@unthsc.edu

• 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