HealthyTA-65MDNCT02766790
Effect of TA-65MD on Healthy Volunteers
A study testing TA-65MD in people with Healthy, run by Telomerase Activation Sciences, Inc at 1 site in United States.
Trial summary
TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres. A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end of the chromosome from deterioration. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TA-65MD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males or females, based on medical history and current status.
- Ages 45-75 years of age (inclusive at the time of Screening).
- Voluntary consent and methods completion of a signed ICF (informed consent form).
- BMI that is 18 to 40 kg/m2 (inclusive at the time of Screening).
- Subjects who are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
- -
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- History of HIV, Hepatitis B, or Hepatitis C.
- Females who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Recent or current medical condition that might significantly affect a pharmacodynamic response or compromise the safety of the subject or impact the validity of the study results in the opinion of the Investigator. (e.g., conditions that require taking diuretic medications and/or cardiac stimulants.)
- Intake of the investigational product within 30 days prior to screening visit.
- History of an allergic reaction to the study products or ingredient(s) or to comparable products in the opinion of the Investigator.
Show all 10Show fewer
- History of drug or alcohol addiction or abuse within 1 year prior to Day -1 product administration through end of study (EOS).
- Donation of blood within 30 days or plasma within 7 days, prior to Day -1 product administration through EOS.
- Intolerance to venipuncture or an inability to swallow capsules.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
QPS Bio-Kinetic, LLC
Springfeild, Missouri, 65802
Brendon Bourg, 417-425-3033, brendon.bourg@qps.com
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period
TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres. A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end of the chromosome from deterioration. They shorten during cell division and eventually signal an irreversible state of growth arrest known as cellular senescence. The length of a person's telomeres is an indicator of his or her overall health status; short telomeres have been associated with cellular aging and dysfunction.
Read the detailed description
The purpose of this clinical study is to evaluate the effects of TA-65 MD® on telomere length and on immunosenescence in subjects who have had 9 months of twice daily TA-65 MD® administration, compared to placebo. TA Sciences has developed different doses of TA-65® . The study intends to determine effect of four different doses of TA-65 MD® in terms of biomarkers, telomere length and overall health and sleep status.
- Conditions
- Healthy
- Being tested
- TA-65MD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-65MDDietary supplement
TA-65, a purified small molecule extracted from Astragalus root
PlaceboOther
Placebo, an inactive formulation
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo taken once daily in the morning and once daily in the evening Receives: Other: Placebo |
| TA-65MD 100 units Dose | Active comparator | TA-65MD 100 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. Receives: Dietary Supplement: TA-65MD |
| TA-65MD 250 units Dose | Active comparator | TA-65MD 250 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. Receives: Dietary Supplement: TA-65MD |
| TA-65MD 500 units Dose | Active comparator | TA-65MD 500 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. Receives: Dietary Supplement: TA-65MD |
| TA-65MD 250 units a.m. and p.m. Dose | Active comparator | Two TA-65MD 250 units capsules; one of them will be taken in the a.m. and one of them will be taken in the p.m. Receives: Dietary Supplement: TA-65MD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Immunesenescent cells
Percent of CD3+/CD8+/CD28-, CD3+/CD8+/CD95-, CD8+/CD28-, CD8+/CD95- from whole blood will be measured at baseline and at 9 months. Change in the percent levels of immunesenescent cells in each group compared to baseline and placebo will be evaluated.
Measured: 9 months
Secondary outcomes (2)
clinical laboratory markers
Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Serum creatinine will be measured at screening and at the end of the study. Standard reference range will be followed for these markers.
Measured: 9 months
Telomere length
The change in telomere length in kilobase pair (kb) in each group will be evaluated from baseline.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telomerase Activation Sciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Burkindine, D.O, Principal investigator, QPS Holdings LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766790
- Sponsor's protocol ID
- 53816
- Acronym
- TA-65MD
- Status last verified
- Jun 2016
- First submitted
- 5 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period
- ClinicalTrials.gov ID
- NCT02766790
- Acronym / sponsor ID
- TA-65MD / 53816
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Telomerase Activation Sciences, IncIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TA-65 MD® is pure, natural, plant-based compound that can help maintain or rebuild telomeres. A telomere is a region of repetitive DNA at the end of a chromosome, which protects the end of the chromosome from deterioration. They shorten during cell division and eventually signal an irreversible state of growth arrest known as cellular senescence. The length of a person's telomeres is an indicator of his or her overall health status; short telomeres have been associated with cellular aging and dysfunction.
Detailed description
The purpose of this clinical study is to evaluate the effects of TA-65 MD® on telomere length and on immunosenescence in subjects who have had 9 months of twice daily TA-65 MD® administration, compared to placebo. TA Sciences has developed different doses of TA-65® . The study intends to determine effect of four different doses of TA-65 MD® in terms of biomarkers, telomere length and overall health and sleep status.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo taken once daily in the morning and once daily in the evening |
| TA-65MD 100 units Dose | Active comparator | Dietary Supplement: TA-65MDTA-65MD 100 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. |
| TA-65MD 250 units Dose | Active comparator | Dietary Supplement: TA-65MDTA-65MD 250 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. |
| TA-65MD 500 units Dose | Active comparator | Dietary Supplement: TA-65MDTA-65MD 500 units capsule and placebo capsule; one of them will be taken in the a.m. and one of them will be taken in the p.m. |
| TA-65MD 250 units a.m. and p.m. Dose | Active comparator | Dietary Supplement: TA-65MDTwo TA-65MD 250 units capsules; one of them will be taken in the a.m. and one of them will be taken in the p.m. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult males or females, based on medical history and current status.
- Ages 45-75 years of age (inclusive at the time of Screening).
- Voluntary consent and methods completion of a signed ICF (informed consent form).
- BMI that is 18 to 40 kg/m2 (inclusive at the time of Screening).
- Subjects who are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
Key exclusion criteria (10 listed)
- History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- History of HIV, Hepatitis B, or Hepatitis C.
- Females who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Recent or current medical condition that might significantly affect a pharmacodynamic response or compromise the safety of the subject or impact the validity of the study results in the opinion of the Investigator. (e.g., conditions that require taking diuretic medications and/or cardiac stimulants.)
- Intake of the investigational product within 30 days prior to screening visit.
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 |
|---|---|---|
| TA-65MDTA-65, a purified small molecule extracted from Astragalus root | Dietary supplement | TA-65MD 100 units Dose, TA-65MD 250 units Dose, TA-65MD 250 units a.m. and p.m. Dose, TA-65MD 500 units Dose |
| PlaceboPlacebo, an inactive formulation | Other | Placebo |
Primary outcome
Percent of Immunesenescent cells
Time frame: 9 months
Percent of CD3+/CD8+/CD28-, CD3+/CD8+/CD95-, CD8+/CD28-, CD8+/CD95- from whole blood will be measured at baseline and at 9 months. Change in the percent levels of immunesenescent cells in each group compared to baseline and placebo will be evaluated.
2 secondary outcomes
clinical laboratory markers
Time frame: 9 months
Telomere length
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Donald Burkindine, D.O principal investigator
QPS Holdings LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TA-65MD in people with Healthy, run by Telomerase Activation Sciences, Inc 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald Burkindine, D.O (4178310456, donald.burkindine@qps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Immunesenescent cells (time frame: 9 months). 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 3 Jun 2016.