Randomized Controlled Trial on Vitamin C Supolementation for HealthRegulation in Middle-Aged and Elderly Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Evaluate the effectiveness of vitamin C in intervening in aging
研究概览
简要总结
The purpose of this clinical trial is to understand whether oral vitamin C can help delay the aging of middle-aged and elderly individuals, search for sensitive biomarkers of human aging, and provide new paradigms and scientific guidance for aging intervention with small molecule drugs. The main questions it aims to answer are as follows:
- Can oral vitamin C effectively improve the aging-related indicators?
- What is the safety of participants when taking vitamin C supplements?
Researchers will compare vitamin C with a placebo to observe whether vitamin C is effective in intervening in the aging of middle-aged and elderly individuals. Participants need to:
- Take 2 tablets (250mg/tablet) of vitamin C or placebo after breakfast and dinner every day for 12 consecutive months;
- Go to the designated place for a face-to-face follow-up every 6 months and receive a telephone follow-up every 2 months, and pick up subsequent drugs during the follow-up;
- Honestly inform the medication situation during each follow-up;
- Report any discomfort or adverse reactions that occur during the treatment process to the researchers;
- Fill in a questionnaire about their own health status during each follow-up;
- After 6 months and 12 months of intervention, conduct a comprehensive health examination as required, including blood tests and other items.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 55-65 years (for the experimental and control groups) or 18-70 years (for the baseline control group assessing aging changes).
- •Health Status: Deemed to be in good health based on medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Weight: BMI within the range of 18.5-28 kg/m².
- •Informed Consent: Capable of signing the informed consent form and complying with the requirements and restrictions outlined in the study protocol.
排除标准
- •Disease Status:Uncontrolled medical conditions or any disease that, in the investigator's opinion, may pose an inappropriate risk or contraindication or interfere with the study's objectives, conduct, or evaluation.Severe chronic or acute diseases (e.g., cancer, heart failure, renal insufficiency, COPD, diabetes, active liver disease, metabolic acidosis, poorly controlled hypertension, epilepsy, recent cardiovascular events, inflammatory bowel disease, neurological disorders, infectious diseases, severe autoimmune diseases, etc.).
- •Weight: BMI < 18.5 or BMI >
- •Substance/Alcohol Abuse: Ongoing alcohol or drug abuse, or excessive alcohol consumption.
- •Medical History: History of gastrointestinal diseases, hyperuricemia, kidney or urinary tract stones, glucose-6-phosphate dehydrogenase deficiency, or paroxysmal nocturnal hemoglobinuria.
- •Allergy: Allergy to vitamin C or any component of its formulation.
- •Recent Medication Use: Use of high-dose vitamin C, vitamin E, low-dose aspirin, acarbose, metformin, NMN/NR, or other anti-aging/weight-loss drugs within the past 3 months.
- •Informed Consent: Inability to provide informed consent.
- •Other: Any physical condition that, in the investigator's opinion, may adversely affect the study process or outcomes.
- •Clinical Research Participation: Participation in any other clinical research within 3 months prior to screening or during the study period, or receipt of chemotherapy, radiotherapy, biologic therapy, small-molecule therapeutic agents, or investigational drugs, with incomplete recovery from related side effects (excluding alopecia or potential neuropathy).
研究组 & 干预措施
Placebo
Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time.
干预措施: Placebo (Other)
Baseline control
Recruit 100 healthy individual volunteers aged 18 - 70 years old (20 volunteers in the age range of 18 - 30, 20 in 30 - 40, 20 in 40 - 50, 20 in 50 - 60, and 20 in 60 - 70, with an equal number of males and females in each age group) as the baseline control for age-related changes. This group will not receive any intervention.
Vitamin C
Participants will take the synthetic vitamin C twice a day, 500mg per time
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
Evaluate the effectiveness of vitamin C in intervening in aging
时间窗: 12 months
DNA methylation composite clock
次要结局
- proteomics(12 months)
- Cardiovascular disease(1 year)
- gut microbiome(12 months)
- Vitamin C level(1 year)
- Cognitive function(1 year)
- Physical Fitness Test(1 year)
- Maximal oxygen consumption(1 year)
- Motor Function(1 year)
- muscle mass(1 year)
- blood cell transcriptomics(12 months)
- metabolomics(12 months)
研究者
Jie Qiao
Professor
Peking University Third Hospital