Clinical trial NCT05603455: Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)
Official title: Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years) - a Multicenter, Double-blind, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Adults (45-65 Years)
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
First posted: 2022-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multicenter, double-blind, randomized, controlled study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 45-65 years of age.
2. 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
3. Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Known history of tumor.
2. women who are breastfeeding.
3. Those who wish to continue having children.
4. those who are unable to cooperate with investigations and testing
5. abuse of drugs, alcohol or other substances.
6. history of cardiac disease: atherosclerotic disease, heart failure, unstable angina, stable angina, etc. and chronic hypoxic diseases: emphysema, pulmonary heart disease, etc.
7. history of chronic gastrointestinal diseases (pancreatitis, IBS) and intestinal surgery.
8. endocrine disease with hyperthyroidism or cortisolism.
9. abnormal liver function, with ALT（Alanine transaminase）/AST（Aspartate aminotransferase） exceeding 2 times the upper limit of normal.
10. abnormal renal function with blood creatinine ≥ 133 μmol/L.
11. Type I diabetes or insulin-dependent type II diabetes.
12. poorly controlled chronic disease (hypertension, hyperlipidemia, type II diabetes, etc.) that is clinically unstable.
13. Vulnerable groups, including critically ill, mentally ill, cognitively impaired, minors, pregnant women, illiterate, etc.

Primary outcomes:
measure: Aging Ai 3.0
timeFrame: Change from Baseline physiological age calculated by Aging Ai 3.0 at 6 months
measure: Fasting glucose in mmol/L
timeFrame: Change from Baseline Fasting glucose at 6 months
measure: BMI（Body Mass Index）in kg/m^2 BMI
timeFrame: Change from Baseline BMI in kg/m^2 at 6 months
measure: Epigenetic clock
timeFrame: Change from Baseline physiological age calculated by Epigenetic clock at 6 months
measure: Bone density in g/cm^3
timeFrame: Change from Baseline Bone density in g/cm3 at 6 months
measure: Triglycerides in mmol/L
timeFrame: Change from Baseline Triglycerides at 6 months
measure: Cholesterol in mmol/L
timeFrame: Change from Baseline Cholesterol at 6 months
measure: Telomere level
timeFrame: Change from Baseline Telomere level at 6 months
measure: Blood pressure
timeFrame: Change from Baseline Systolic Blood Pressure and diastolic blood pressure at 6 months
measure: body fat percentage
timeFrame: Change from Baseline body fat percentage at 6 months
measure: Markers for cell senescence
timeFrame: Change from Baseline the expression level of indicators at 6 months
Secondary outcomes:
measure: Flora Clock
timeFrame: Change from Baseline physiological age calculated by Flora Clock at 6 months
measure: Mini-Nutritional Assessment
timeFrame: Change from Baseline score at 6 months
measure: The Medical Outcomes Study Short Form 36(SF-36)
timeFrame: Change from Baseline score at 6 months
measure: Pittsburgh sleep quality index
timeFrame: Change from Baseline score at 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir RUN RUN Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: liangjing wang, doctor
role: STUDY_CHAIR
References: