Effect of TA-65MD on Healthy Volunteers

T

Telomerase Activation Sciences

Status

Unknown

Conditions

Healthy

Treatments

Other: Placebo
Dietary Supplement: TA-65MD

Study type

Interventional

Funder types

Industry

Identifiers

NCT02766790
53816

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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. -

Trial design

500 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo taken once daily in the morning and once daily in the evening
Treatment:
Other: Placebo
TA-65MD 100 units Dose
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: TA-65MD
TA-65MD 250 units Dose
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: TA-65MD
TA-65MD 500 units Dose
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: TA-65MD
TA-65MD 250 units a.m. and p.m. Dose
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: TA-65MD

Trial contacts and locations

1

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Central trial contact

Donald Burkindine, D.O

Data sourced from clinicaltrials.gov

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