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NCT05603455
Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)
Conditions: Healthy Adults (45-65 Years)
Sex: All
Ages: 45 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Location: China
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: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 UniversityVoluntarily 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 testingabuse 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.
Source: ClinicalTrials.gov (NCT05603455). StuddyBuddy aggregates publicly available trial information.