Adult Stem Cell ProliferationPhase 2NCT01847027
Exercise and NutraStem (NT-020): Effects on Stem Cells
A Phase 2 study testing NutraStem in people with Adult Stem Cell Proliferation, run by University of North Texas Health Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Stem Cell Proliferation
- What is being tested?
- NutraStem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 17 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
- Age 50 to 70 years old
- Ability to walk on a treadmill for 15 minutes.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center - Center for Biohealth
Fort Worth, Texas, 76107
About this study
Official title: Phase 2 Study of the Effect of a Nutritional Supplement and Exercise on Human Stem Cells
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.
Read the detailed description
A randomized double blinded placebo controlled trial of a nutraceutical preparation. Up to 60 men and women between the ages of 50 and 70, and generally healthy will participate in this study. . Up to 30 participants will receive the nutritional supplement and up to 30 will receive placebo.
Potential participants will be screened by telephone and have the study explained to them in detail. If they qualify and choose to participate they will come in for the first of three visits. Informed consent will be obtained and demographic information collected. Information requested on the demographic form includes ethnicity, income, education, marital status, smoking and alcohol use, and exercise habits. Next they will have blood pressure checked and if not within parameters they will be dropped from the study and informed that they need to follow up the abnormal result with their health care provider. Those that pass these screening tests will have 15 to 25 cc's of peripheral blood (serum) collected by the study coordinator via venipuncture while at rest. They will then stretch for 2 minutes (60 seconds marching in place followed by 10 toe touches) followed by accelerating treadmill walking exercise. The exercise intervention will consist of a 15 minute period of walking on a treadmill. The treadmill will not be inclined during the intervention. The participants target heart rate will be determined by deducting their age from 220. They will start walking on the treadmill at a speed of 1.7 mph and the speed will be titrated as indicated to keep their heart rate at 50 to 90% of target. Heart rate will be monitored via the pulse oximetry feature of the Welch Allyn vital signs monitor. Blood pressure will be measured every 3 minutes during the exercise intervention and until they have returned to baseline (within 10 points) following cessation of the exercise protocol. The test will be stopped for any participant complaint of chest pain, excess fatigue, difficulty breathing, a blood pressure reading of more than 180/94, or a participant request. If symptoms increase or do not completely resolve with 15 minutes of rest the study coordinator will call 911 (through campus police) to activate the EMS response. If symptoms resolve completely within 15 minutes participants will be withdrawn from the study and advised to follow up with their health care provider. Any participant unable to complete the exercise intervention for any reason will be withdrawn from the study.
Five to fifteen minutes after the exercise intervention has been completed blood will again be collected in exactly the same manner as the resting sample. Participants will then receive a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every morning and evening before meals for the next 2 weeks. If the participant is unable to complete any portion of the visit activities at any visit they will be withdrawn from the study due to their inability to complete the study. All visit activities will be recorded in detail on the visit session record.
The second visit will occur 2 weeks later and include a blood pressure check, an at rest blood draw, the exercise intervention, and then a repeat blood draw five to fifteen minutes after completion of the intervention. Participants will then receive a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every morning and evening before meals for the next 2 weeks. I Participants will be advised to bring their empty pill containers to their next session so we can confirm they are taking the supplement as required. If the blood pressure is outside of the specified range they will be dropped from the study and no blood collection or study intervention will take place.
The third visit will be the same as the second visit.
- Conditions
- Adult Stem Cell Proliferation
- Being tested
- NutraStem, Placebo
- Keywords
- Healthy, Stem cells, Aging, Increase stem cell replacement, decreased stem cell proliferation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraStemDrug
Also called NT-020
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.
PlaceboDrug
Also called Sugar pill
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.
| Study group | Role | What they receive |
|---|---|---|
| Active supplement | Active comparator | NutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). Receives: Drug: NutraStem |
| Sugar pill | 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CD133+ Cells
The percentage of CD133+ cells detected in blood samples
Measured: Baseline, 2 weeks, 4 weeks
Percent of CD34+ Cells
Percent of CD34+ cells detected in blood samples
Measured: Baseline, 2 weeks, 4 weeks
Secondary outcomes (1)
Markers of Oxidative Stress
Blood levels of C reactive protein
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completion17 Jul 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Stem Cell ProliferationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida
- Responsible party
- Principal investigator, Meharvan Singh, University of North Texas Health Science Center
- Investigators
- Meharvan Singh, PhD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847027
- Sponsor's protocol ID
- 2012-162
- Status last verified
- May 2019
- First submitted
- 1 May 2013
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Effect of a Nutritional Supplement and Exercise on Human Stem Cells
- ClinicalTrials.gov ID
- NCT01847027
- Acronym / sponsor ID
- 2012-162
- Conditions
- Adult Stem Cell Proliferation
- Keywords
- Healthy, Stem cells, Aging, Increase stem cell replacement, decreased stem cell proliferation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- University of South Florida
- Study start
- Apr 2013 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized double blinded placebo controlled trial of a nutraceutical preparation. Up to 60 men and women between the ages of 50 and 70, and generally healthy will participate in this study. . Up to 30 participants will receive the nutritional supplement and up to 30 will receive placebo.
Potential participants will be screened by telephone and have the study explained to them in detail. If they qualify and choose to participate they will come in for the first of three visits. Informed consent will be obtained and demographic information collected. Information requested on the demographic form includes ethnicity, income, education, marital status, smoking and alcohol use, and exercise habits. Next they will have blood pressure checked and if not within parameters they will be dropped from the study and informed that they need to follow up the abnormal result with their health care provider. Those that pass these screening tests will have 15 to 25 cc's of peripheral blood (serum) collected by the study coordinator via venipuncture while at rest. They will then stretch for 2 minutes (60 seconds marching in place followed by 10 toe touches) followed by accelerating treadmill walking exercise. The exercise intervention will consist of a 15 minute period of walking on a treadmill. The treadmill will not be inclined during the intervention. The participants target heart rate will be determined by deducting their age from 220. They will start walking on the treadmill at a speed of 1.7 mph and the speed will be titrated as indicated to keep their heart rate at 50 to 90% of target. Heart rate will be monitored via the pulse oximetry feature of the Welch Allyn vital signs monitor. Blood pressure will be measured every 3 minutes during the exercise intervention and until they have returned to baseline (within 10 points) following cessation of the exercise protocol. The test will be stopped for any participant complaint of chest pain, excess fatigue, difficulty breathing, a blood pressure reading of more than 180/94, or a participant request. If symptoms increase or do not completely resolve with 15 minutes of rest the study coordinator will call 911 (through campus police) to activate the EMS response. If symptoms resolve completely within 15 minutes participants will be withdrawn from the study and advised to follow up with their health care provider. Any participant unable to complete the exercise intervention for any reason will be withdrawn from the study.
Five to fifteen minutes after the exercise intervention has been completed blood will again be collected in exactly the same manner as the resting sample. Participants will then receive a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every morning and evening before meals for the next 2 weeks. If the participant is unable to complete any portion of the visit activities at any visit they will be withdrawn from the study due to their inability to complete the study. All visit activities will be recorded in detail on the visit session record.
The second visit will occur 2 weeks later and include a blood pressure check, an at rest blood draw, the exercise intervention, and then a repeat blood draw five to fifteen minutes after completion of the intervention. Participants will then receive a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every morning and evening before meals for the next 2 weeks. I Participants will be advised to bring their empty pill containers to their next session so we can confirm they are taking the supplement as required. If the blood pressure is outside of the specified range they will be dropped from the study and no blood collection or study intervention will take place.
The third visit will be the same as the second visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active supplement | Active comparator | Drug: NutraStemNutraStem, 2 tablets daily, Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). |
| Sugar pill | Placebo comparator | Drug: PlaceboThe 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) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Age 50 to 70 years old
- Ability to walk on a treadmill for 15 minutes.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutraStemAlso: NT-020Determine 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. | Drug | Active supplement |
| PlaceboAlso: Sugar pillDetermine 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. | Drug | Sugar pill |
Primary outcome
Percentage of CD133+ Cells
Time frame: Baseline, 2 weeks, 4 weeks
The percentage of CD133+ cells detected in blood samples
Percent of CD34+ Cells
Time frame: Baseline, 2 weeks, 4 weeks
Percent of CD34+ cells detected in blood samples
1 secondary outcome
Markers of Oxidative Stress
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Adult Stem Cell Proliferation
Active, not recruitingPhase 3
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meharvan Singh, PhD principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NutraStem in people with Adult Stem Cell Proliferation, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CD133+ Cells (time frame: Baseline, 2 weeks, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.