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Trial record 1 of 5 for:    TA-65
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Effect of TA-65MD on Healthy Volunteers (TA-65MD)

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ClinicalTrials.gov Identifier: NCT02766790
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Healthy Dietary Supplement: TA-65MD Other: Placebo

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo taken once daily in the morning and once daily in the evening
Other: Placebo
Placebo, an inactive formulation
Active Comparator: TA-65MD 100 units Dose
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.
Dietary Supplement: TA-65MD
TA-65, a purified small molecule extracted from Astragalus root
Active Comparator: TA-65MD 250 units Dose
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.
Dietary Supplement: TA-65MD
TA-65, a purified small molecule extracted from Astragalus root
Active Comparator: TA-65MD 500 units Dose
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.
Dietary Supplement: TA-65MD
TA-65, a purified small molecule extracted from Astragalus root
Active Comparator: TA-65MD 250 units a.m. and p.m. Dose
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.
Dietary Supplement: TA-65MD
TA-65, a purified small molecule extracted from Astragalus root


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. clinical laboratory markers [ Time Frame: 9 months ]
    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.

  2. Telomere length [ Time Frame: 9 months ]
    The change in telomere length in kilobase pair (kb) in each group will be evaluated from baseline.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult males or females, based on medical history and current status.
  2. Ages 45-75 years of age (inclusive at the time of Screening).
  3. Voluntary consent and methods completion of a signed ICF (informed consent form).
  4. BMI that is 18 to 40 kg/m2 (inclusive at the time of Screening).
  5. Subjects who are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.

Exclusion Criteria:

  1. 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.
  2. History of HIV, Hepatitis B, or Hepatitis C.
  3. Females who are pregnant, planning to become pregnant during the study, or breastfeeding.
  4. 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.)
  5. Intake of the investigational product within 30 days prior to screening visit.
  6. History of an allergic reaction to the study products or ingredient(s) or to comparable products in the opinion of the Investigator.
  7. History of drug or alcohol addiction or abuse within 1 year prior to Day -1 product administration through end of study (EOS).
  8. Donation of blood within 30 days or plasma within 7 days, prior to Day -1 product administration through EOS.
  9. Intolerance to venipuncture or an inability to swallow capsules.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766790


Contacts
Contact: Donald Burkindine, D.O 4178310456 donald.burkindine@qps.com

Locations
United States, Missouri
QPS Bio-Kinetic, LLC Recruiting
Springfeild, Missouri, United States, 65802
Contact: Brendon Bourg    417-425-3033    brendon.bourg@qps.com   
Sponsors and Collaborators
Telomerase Activation Sciences, Inc
Investigators
Principal Investigator: Donald Burkindine, D.O QPS, LLC
More Information

Responsible Party: Telomerase Activation Sciences, Inc
ClinicalTrials.gov Identifier: NCT02766790     History of Changes
Other Study ID Numbers: 53816
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided