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

Zhejiang University

Status: Not yet enrolling

Conditions: Healthy Adults (45-65 Years)

Treatments: Dietary Supplement: Bifidobacterium adolescentis; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05603455

2022-LHZHZ

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Bifidobacterium adolescentis group

Experimental group

Description:

Bifidobacterium adolescentis supplementation

Treatment:

Dietary Supplement: Bifidobacterium adolescentis

Placebo group

Placebo Comparator group

Description:

Placebo supplementation

Treatment:

Dietary Supplement: Placebo