Effect of TA-65MD on Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 45 - 75 |
| Updated: | 6/4/2016 |
| Start Date: | May 2016 |
| End Date: | July 2017 |
| Contact: | Donald Burkindine, D.O |
| Email: | donald.burkindine@qps.com |
| Phone: | 4178310456 |
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.
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.
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.
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.
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.
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