A Randomized, Double Blind, Placebo Controlled, Parallel Study of TA-65MD in Healthy Volunteers Evaluating Immunosenescence and Telomere Length Over a Nine Month Period
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Percent of Immunesenescent cells
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percent of Immunesenescent cells
时间窗: 9 months
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.
次要结局
- clinical laboratory markers(9 months)
- Telomere length(9 months)