Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years) - a Multicenter, Double-blind, Randomized, Controlled Study

Conditions
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Healthy Adults (45-65 Years)

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium adolescentis
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a multicenter, double-blind, randomized, controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium adolescentis group<br>Bifidobacterium adolescentis supplementation | Dietary Supplement: Bifidobacterium adolescentis<br>* Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months<br>|
| Placebo Comparator: Placebo group<br>Placebo supplementation | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aging Ai 3.0 | Calculating physiological age through physical examination indicators.The lower the physiological age calculated by Aging Ai 3.0, the better the health status. | Change from Baseline physiological age calculated by Aging Ai 3.0 at 6 months | 
| Fasting glucose in mmol/L | Within the normal range（3.9 6.1 mmol/L）, the health status is good | Change from Baseline Fasting glucose at 6 months | 
| BMI（Body Mass Index）in kg/m^2 BMI | Within the normal range, the health status is good | Change from Baseline BMI in kg/m^2 at 6 months | 
| Epigenetic clock | physiological age was calculated by Epigenetic clock through DNA methylation.The lower the physiological age calculated by Epigenetic clock, the better the health status. | Change from Baseline physiological age calculated by Epigenetic clock at 6 months | 
| Bone density in g/cm^3 | The higher the Bone density, the better the health status | Change from Baseline Bone density in g/cm3 at 6 months | 
| Triglycerides in mmol/L | Within the normal range（2.26 5.6 mmol/L）, the health status is good | Change from Baseline Triglycerides at 6 months | 
| Cholesterol in mmol/L | Within the normal range（3.6 5.2 mmol/L）, the health status is good | Change from Baseline Cholesterol at 6 months | 
| Telomere level | 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. | Change from Baseline Telomere level at 6 months | 
| Blood pressure | Within the normal range, the health status is good | Change from Baseline Systolic Blood Pressure and diastolic blood pressure at 6 months | 
| body fat percentage | The higher the body fat percentage, the better the health status | Change from Baseline body fat percentage at 6 months | 
| Markers for cell senescence | 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. | Change from Baseline the expression level of indicators at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flora Clock | Calculating physiological age through intestinal flora.The lower the physiological age calculated by Flora Clock, the better the health status. | Change from Baseline physiological age calculated by Flora Clock at 6 months | 
| Mini-Nutritional Assessment | The score (0-30)was calculated by Mini-Nutritional Assessment. The higher score calculated by Mini-Nutritional Assessment means a better outcome | Change from Baseline score at 6 months | 
| The Medical Outcomes Study Short Form 36(SF-36) | 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 | Change from Baseline score at 6 months | 
| Pittsburgh sleep quality index | The score (0-21)was calculated by Pittsburgh sleep quality index The higher score calculated by Pittsburgh sleep quality index means a worse outcome | Change from Baseline score at 6 months |