A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Evaluating Tocotrienol-Rich Fraction as a Senolytic Agent in Middle-Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to determine whether tocotrienol works as a senolytic agent to delay age-related biological changes in middle-aged adults. The study will also evaluate the safety of tocotrienol supplementation. The main questions it aims to answer are:
Does tocotrienol reduce markers of cellular senescence, inflammation, oxidative stress, and mitochondrial dysfunction?
What health changes or medical issues occur in participants taking tocotrienol?
Researchers will compare tocotrienol-rich fraction to a placebo (a look-alike capsule with no active ingredient) to determine whether tocotrienol is effective in modulating aging-related pathways.
Participants will:
Take tocotrienol (200 mg/day) or a placebo daily for 6 months
Attend study visits at baseline, 3 months, and 6 months for clinical assessments and laboratory tests
Undergo blood sampling and health evaluations, including measures of senescence-associated secretory phenotype (SASP), inflammation, oxidative stress, mitochondrial function, vascular health, skin status, cognitive function, body composition, and bone mineral density.
Complete questionnaires related to diet throughout the study period
This study aims to provide clinical evidence on the potential of tocotrienol as a senolytic intervention for promoting healthy aging and reducing the risk of age-related diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy as assessed by physical examination and blood lab test, including adequate liver and renal function, Neutrophil count > 1500/mm3, Platelet count 120,000 - 450,000/mm3, Haemoglobin concentration 11.5 to 19.0g/dL for men; 10.5-17.5 g/dL for women, Prothrombin and partial thromboplastin time within normal range, ALT and AST < 80 IU/L, Creatinine 0.7 to 1.3 mg/dL
- •Subject of either gender, 35 to 64 years of age (inclusive)
- •Not allergy to palm oil and vitamin E
- •Do not take vitamin E supplements over the past 3 months
- •Provide written informed consent prior to screening
- •Subject is willing and able to comply with the study visit schedule and procedure, geographic proximity (investigator's discretion) that allows adequate follow up
- •Subjects understand the study protocol and signed informed consent forms
排除标准
- •Subjects with fat malabsorption
- •Subjects with chronic conditions such as cardiac diseases (heart failure, myocardial infraction, ischemic heart disease), neurological diseases, diabetes, HIV infection, psychiatric illness/social situations
- •Subjects with vegan diet
- •Current smoker or used to smoke in the past 3 months
- •Subject for surgery or had undergone surgery in the past 3 months
- •Current or past history of drug, alcohol abuse and cancer
- •Pregnant and lactating women
- •History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
- •Any subject taking antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols
- •Subjects who are pre-disposed to inherited blood/circulation disorders
- •Subject who is taking anticoagulants and antithrombotic drugs, e.g. warfarin, aspirin, ticlopidine, heparin, etc.