Healthy Adults (45-65 Years)
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium adolescentis
Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Sir Run Run Shaw Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Blinding of both the investigator (except for the investigator responsible for blinded product allocation) and the subject
Intervention model description
a multicenter, double-blind, randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Markers for cell senescence | 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. |
| Cholesterol in mmol/L | Change from Baseline Cholesterol at 6 months | Within the normal range（3.6\ 5.2 mmol/L）, the health status is good |
| Telomere level | 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. |
| Blood pressure | 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 | Change from Baseline body fat percentage at 6 months | The higher the body fat percentage, the better the health status |
| Aging Ai 3.0 | 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. |
| Fasting glucose in mmol/L | 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 | Change from Baseline BMI in kg/m^2 at 6 months | Within the normal range, the health status is good |
| Epigenetic clock | 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. |
| Bone density in g/cm^3 | 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 | Change from Baseline Triglycerides at 6 months | Within the normal range（2.26\ 5.6 mmol/L）, the health status is good |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Nutritional Assessment | Change from Baseline score at 6 months | The score (0-30)was calculated by Mini-Nutritional Assessment. The higher score calculated by Mini-Nutritional Assessment means a better outcome |
| The Medical Outcomes Study Short Form 36(SF-36) | Change from Baseline score at 6 months | The score (36-145)was calculated by The Medical Outcomes Study Short Form 36. The higher score calculated by The Medical Outcomes Study Short Form 36 means a better outcome |
| Pittsburgh sleep quality index | Change from Baseline score at 6 months | The score (0-21)was calculated by Pittsburgh sleep quality index The higher score calculated by Pittsburgh sleep quality index means a worse outcome |
| Flora Clock | Change from Baseline physiological age calculated by Flora Clock at 6 months | Calculating physiological age through intestinal flora.The lower the physiological age calculated by Flora Clock, the better the health status. |
Countries
China
Contacts
Primary Contactliangjing wang, doctor
Backup Contactchaochao xu, doctor
Outcome results
None listed