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Effect of TA-65MD on Healthy Volunteers (TA-65MD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766790
Recruitment Status : Unknown
Verified June 2016 by Telomerase Activation Sciences, Inc.
Recruitment status was:  Recruiting
First Posted : May 10, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Telomerase Activation Sciences, Inc

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
% of Immunosenescent cells and telomere length in kilo base pairs [ Time Frame: 9 months ]
% of CD3+/CD8+/CD28-, CD3+/CD8+/CD95-, CD8+/CD28-, CD8+/CD95- from whole blood will be measured. Telomere length will be analyzed in peripheral blood mononuclear cells (PBMC). The measurements will be done at baseline and at 9 months; a change in % of immunosenescent cells and telomere length (in kilo base pairs) from baseline would be evaluated.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • 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.
  • Telomere length [ Time Frame: 9 months ]
    The change in telomere length in kilobase pair (kb) in each group will be evaluated from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of TA-65MD on Healthy Volunteers
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: TA-65MD
    TA-65, a purified small molecule extracted from Astragalus root
  • Other: Placebo
    Placebo, an inactive formulation
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo taken once daily in the morning and once daily in the evening
    Intervention: Other: Placebo
  • 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.
    Intervention: Dietary Supplement: TA-65MD
  • 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.
    Intervention: Dietary Supplement: TA-65MD
  • 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.
    Intervention: Dietary Supplement: TA-65MD
  • 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.
    Intervention: Dietary Supplement: TA-65MD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02766790
Other Study ID Numbers  ICMJE 53816
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Telomerase Activation Sciences, Inc
Study Sponsor  ICMJE Telomerase Activation Sciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald Burkindine, D.O QPS, LLC
PRS Account Telomerase Activation Sciences, Inc
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP