Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years) - a Multicenter, Double-blind, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fasting glucose in mmol/L
研究概览
简要总结
This study will include middle-aged and elderly people aged 45-65 years to carry out the translational study of Bifidobacterium adolescentis, and design a double-blind, randomized controlled clinical trial according to strict inclusion/exclusion criteria, using aging-related functional indicators, intestinal flora, DNA methylation and other advanced aging characteristic examination methods to fully and accurately assess the effects and safety of Bifidobacterium adolescentis on aging, which has the advantages of strong safety, high practice and high credibility compared with previous clinical trial protocols, laying an important foundation for improving probiotic anti-aging and exploring the development of aging intervention programs suitable for the Chinese population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinding of both the investigator (except for the investigator responsible for blinded product allocation) and the subject
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45-65 years of age.
- •Attending or consulting at the specialized outpatient clinics for aging diseases at 2nd Affiliated Hospital, School of Medicine, Zhejiang University and Sir Run Run Hospital, School of Medicine, Zhejiang University
- •Voluntarily participate in this study and sign the informed consent form.
排除标准
- •Known history of tumor.
- •women who are breastfeeding.
- •Those who wish to continue having children.
- •those who are unable to cooperate with investigations and testing
- •abuse of drugs, alcohol or other substances.
- •history of cardiac disease: atherosclerotic disease, heart failure, unstable angina, stable angina, etc. and chronic hypoxic diseases: emphysema, pulmonary heart disease, etc.
- •history of chronic gastrointestinal diseases (pancreatitis, IBS) and intestinal surgery.
- •endocrine disease with hyperthyroidism or cortisolism.
- •abnormal liver function, with ALT（Alanine transaminase）/AST（Aspartate aminotransferase） exceeding 2 times the upper limit of normal.
- •abnormal renal function with blood creatinine ≥ 133 μmol/L.
- •Type I diabetes or insulin-dependent type II diabetes.
- •poorly controlled chronic disease (hypertension, hyperlipidemia, type II diabetes, etc.) that is clinically unstable.
- •Vulnerable groups, including critically ill, mentally ill, cognitively impaired, minors, pregnant women, illiterate, etc.
研究组 & 干预措施
Bifidobacterium adolescentis group
Bifidobacterium adolescentis supplementation
干预措施: Bifidobacterium adolescentis (Dietary Supplement)
Placebo group
Placebo supplementation
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fasting glucose in mmol/L
时间窗: Change from Baseline Fasting glucose at 6 months
Within the normal range（3.9\~6.1 mmol/L）, the health status is good
BMI（Body Mass Index）in kg/m^2 BMI
时间窗: Change from Baseline BMI in kg/m^2 at 6 months
Within the normal range, the health status is good
Markers for cell senescence
时间窗: Change from Baseline the expression level of indicators at 6 months
The expression level of Markers for cell senescence was detected by qRT（quantitative real-time）-PCR（Polymerase Chain Reaction）.The higher the Cycle Threshold，the lower the expression level of Markers for cell senescence, which means the healthier.
Aging Ai 3.0
时间窗: Change from Baseline physiological age calculated by Aging Ai 3.0 at 6 months
Calculating physiological age through physical examination indicators.The lower the physiological age calculated by Aging Ai 3.0, the better the health status.
Epigenetic clock
时间窗: Change from Baseline physiological age calculated by Epigenetic clock at 6 months
physiological age was calculated by Epigenetic clock through DNA methylation.The lower the physiological age calculated by Epigenetic clock, the better the health status.
Cholesterol in mmol/L
时间窗: Change from Baseline Cholesterol at 6 months
Within the normal range（3.6\~5.2 mmol/L）, the health status is good
Blood pressure
时间窗: Change from Baseline Systolic Blood Pressure and diastolic blood pressure at 6 months
Within the normal range, the health status is good
body fat percentage
时间窗: Change from Baseline body fat percentage at 6 months
The higher the body fat percentage, the better the health status
Bone density in g/cm^3
时间窗: Change from Baseline Bone density in g/cm3 at 6 months
The higher the Bone density, the better the health status
Triglycerides in mmol/L
时间窗: Change from Baseline Triglycerides at 6 months
Within the normal range（2.26\~5.6 mmol/L）, the health status is good
Telomere level
时间窗: Change from Baseline Telomere level at 6 months
Telomere level was detected by qRT（quantitative real-time）-PCR（Polymerase Chain reaction）. The lower the Cycle Threshold，the higher the Telomere level，which means the healthier and younger.
次要结局
- Mini-Nutritional Assessment(Change from Baseline score at 6 months)
- Pittsburgh sleep quality index(Change from Baseline score at 6 months)
- Flora Clock(Change from Baseline physiological age calculated by Flora Clock at 6 months)
- The Medical Outcomes Study Short Form 36(SF-36)(Change from Baseline score at 6 months)