Effect of TA-65MD on Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: TA-65MD
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. - Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo taken once daily in the morning and once daily in the evening | Other: Placebo<br>* Placebo, an inactive formulation<br>|
| Active Comparator: TA-65MD 100 units Dose<br>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<br>* TA-65, a purified small molecule extracted from Astragalus root<br>|
| Active Comparator: TA-65MD 250 units Dose<br>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<br>* TA-65, a purified small molecule extracted from Astragalus root<br>|
| Active Comparator: TA-65MD 500 units Dose<br>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<br>* TA-65, a purified small molecule extracted from Astragalus root<br>|
| Active Comparator: TA-65MD 250 units a.m. and p.m. Dose<br>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<br>* TA-65, a purified small molecule extracted from Astragalus root<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical laboratory markers | 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. | 9 months | 
| Telomere length | The change in telomere length in kilobase pair (kb) in each group will be evaluated from baseline. | 9 months |