Clinical trial NCT02766790: Effect of TA-65MD on Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Telomerase Activation Sciences, Inc
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

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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.

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Primary outcomes:
measure: Percent of Immunesenescent cells
timeFrame: 9 months
Secondary outcomes:
measure: clinical laboratory markers
timeFrame: 9 months
measure: Telomere length
timeFrame: 9 months
Other outcomes:
Locations:
city: Springfeild
country: United States
facility: QPS Bio-Kinetic, LLC
state: Missouri
Study officials:
affiliation: QPS Holdings LLC
name: Donald Burkindine, D.O
role: PRINCIPAL_INVESTIGATOR
References: