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

NCT ID: NCT05603455

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Healthy Adults (45-65 Years)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a multicenter, double-blind, randomized, controlled study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Blinding of both the investigator (except for the investigator responsible for blinded product allocation) and the subject

Study Groups

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Bifidobacterium adolescentis group

Bifidobacterium adolescentis supplementation

Group Type EXPERIMENTAL

Bifidobacterium adolescentis

Intervention Type DIETARY_SUPPLEMENT

Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months

Placebo group

Placebo supplementation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Bifidobacterium adolescentis

Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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liangjing wang, doctor

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

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Sir RUN RUN Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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liangjing wang, doctor

Role: CONTACT

+86 0571 87783759

chaochao xu, doctor

Role: CONTACT

+86 0571 87783759

Facility Contacts

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shujie chen, doctor

Role: primary

+86 0571 86090073

Other Identifiers

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2022-LHZHZ

Identifier Type: -

Identifier Source: org_study_id

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