Trial Outcomes & Findings for Exercise and NutraStem (NT-020): Effects on Stem Cells (NCT NCT01847027)
NCT ID: NCT01847027
Last Updated: 2019-05-29
Results Overview
The percentage of CD133+ cells detected in blood samples
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline, 2 weeks, 4 weeks
Results posted on
2019-05-29
Participant Flow
Participant milestones
| Measure |
Active Supplement
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.
|
Sugar Pill
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 Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise and NutraStem (NT-020): Effects on Stem Cells
Baseline characteristics by cohort
| Measure |
Active Supplement
n=11 Participants
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.
|
Sugar Pill
n=12 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksPopulation: subjects who completed all three visits and from whom blood draws were obtained
The percentage of CD133+ cells detected in blood samples
Outcome measures
| Measure |
Active Supplement
n=10 Participants
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.
|
Sugar Pill
n=10 Participants
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.
|
|---|---|---|
|
Percentage of CD133+ Cells
Baseline (visit 1)
|
0.50 percent of total
Standard Deviation 0.39
|
0.28 percent of total
Standard Deviation 0.15
|
|
Percentage of CD133+ Cells
2 weeks (visit 2)
|
0.54 percent of total
Standard Deviation 0.49
|
0.47 percent of total
Standard Deviation 0.54
|
|
Percentage of CD133+ Cells
4 weeks (visit 3)
|
0.37 percent of total
Standard Deviation 0.25
|
0.35 percent of total
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksPopulation: Subjects who completed all three visit and from whom blood draws were successful
Percent of CD34+ cells detected in blood samples
Outcome measures
| Measure |
Active Supplement
n=10 Participants
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.
|
Sugar Pill
n=10 Participants
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.
|
|---|---|---|
|
Percent of CD34+ Cells
Baseline (visit 1)
|
9.46 percent of total
Standard Deviation 6.98
|
14.31 percent of total
Standard Deviation 7.4
|
|
Percent of CD34+ Cells
2 weeks (visit 2)
|
7.64 percent of total
Standard Deviation 8.29
|
7.13 percent of total
Standard Deviation 3.97
|
|
Percent of CD34+ Cells
4 weeks (visit 3)
|
7.29 percent of total
Standard Deviation 6.08
|
8.49 percent of total
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Subjects who completed all three visits
Blood levels of C reactive protein
Outcome measures
| Measure |
Active Supplement
n=10 Participants
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.
|
Sugar Pill
n=10 Participants
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.
|
|---|---|---|
|
Markers of Oxidative Stress
Baseline (visit 1)
|
1695848.62 ng/L
Standard Deviation 2084023.54
|
1843643.43 ng/L
Standard Deviation 1391654.22
|
|
Markers of Oxidative Stress
4 weeks (visit 3)
|
873777.84 ng/L
Standard Deviation 647730.33
|
1935423.36 ng/L
Standard Deviation 1096810.43
|
Adverse Events
Active Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Supplement
n=11 participants at risk
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.
|
Sugar Pill
n=12 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
vasovagal response
|
0.00%
0/11 • 4 weeks
Blood pressure is monitored in individuals while exercising (treadmill walking).
|
16.7%
2/12 • Number of events 2 • 4 weeks
Blood pressure is monitored in individuals while exercising (treadmill walking).
|
Additional Information
Meharvan Singh, PhD
University of North Texas Health Science Center
Phone: 8177355429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place