Effect of TA-65MD on Healthy Volunteers
TA-65MD
A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started May 2016
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 3, 2016
June 1, 2016
1 year
May 5, 2016
June 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
9 months
Secondary Outcomes (2)
clinical laboratory markers
9 months
Telomere length
9 months
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo taken once daily in the morning and once daily in the evening
TA-65MD 100 units Dose
ACTIVE COMPARATORTA-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 COMPARATORTA-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 COMPARATORTA-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 COMPARATORTwo 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
QPS Bio-Kinetic, LLC
Springfeild, Missouri, 65802, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Burkindine, D.O
QPS Holdings LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 10, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
July 1, 2017
Last Updated
June 3, 2016
Record last verified: 2016-06