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

February 7, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 317000
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Bifidobacterium adolescentis group
Bifidobacterium adolescentis supplementation
Dietary supplement: Bifidobacterium adolescentis
Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months
PLACEBO_COMPARATOR: Placebo group
Placebo supplementation
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aging Ai 3.0
Time Frame: 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.
Change from Baseline physiological age calculated by Aging Ai 3.0 at 6 months
Fasting glucose in mmol/L
Time Frame: Change from Baseline Fasting glucose at 6 months
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
Time Frame: Change from Baseline BMI in kg/m^2 at 6 months
Within the normal range, the health status is good
Change from Baseline BMI in kg/m^2 at 6 months
Epigenetic clock
Time Frame: 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.
Change from Baseline physiological age calculated by Epigenetic clock at 6 months
Bone density in g/cm^3
Time Frame: Change from Baseline Bone density in g/cm3 at 6 months
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
Time Frame: Change from Baseline Triglycerides at 6 months
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
Time Frame: Change from Baseline Cholesterol at 6 months
Within the normal range（3.6~5.2 mmol/L）, the health status is good
Change from Baseline Cholesterol at 6 months
Telomere level
Time Frame: 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.
Change from Baseline Telomere level at 6 months
Blood pressure
Time Frame: Change from Baseline Systolic Blood Pressure and diastolic blood pressure at 6 months
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
Time Frame: Change from Baseline body fat percentage at 6 months
The higher the body fat percentage, the better the health status
Change from Baseline body fat percentage at 6 months
Markers for cell senescence
Time Frame: 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.
Change from Baseline the expression level of indicators at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Flora Clock
Time Frame: 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.
Change from Baseline physiological age calculated by Flora Clock at 6 months
Mini-Nutritional Assessment
Time Frame: 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
Change from Baseline score at 6 months
The Medical Outcomes Study Short Form 36(SF-36)
Time Frame: 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
Change from Baseline score at 6 months
Pittsburgh sleep quality index
Time Frame: 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
Change from Baseline score at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-LHZHZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings