Healthy Adults (45-65 Years)NCT05603455
Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)
A study testing Bifidobacterium adolescentis in people with Healthy Adults (45-65 Years), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults (45-65 Years)
- What is being tested?
- Bifidobacterium adolescentis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir RUN RUN Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 317000
shujie chen, doctor, +86 0571 86090073, chenshujie77@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Healthy Adults (45-65 Years)
- Being tested
- Bifidobacterium adolescentis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium adolescentisDietary supplement
Supplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium adolescentis group | Experimental | Bifidobacterium adolescentis supplementation Receives: Dietary Supplement: Bifidobacterium adolescentis |
| Placebo group | Placebo comparator | Placebo supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from Baseline Telomere level at 6 months
Blood pressure
Within the normal range, the health status is good
Measured: 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
Measured: 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.
Measured: Change from Baseline the expression level of indicators at 6 months
Secondary outcomes (4)
Flora Clock
Calculating physiological age through intestinal flora.The lower the physiological age calculated by Flora Clock, the better the health status.
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline score at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adults (45-65 Years)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a multicenter, double-blind, randomized, controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- liangjing wang, doctor, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603455
- Sponsor's protocol ID
- 2022-LHZHZ
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years) - a Multicenter, Double-blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05603455
- Acronym / sponsor ID
- 2022-LHZHZ
- Conditions
- Healthy Adults (45-65 Years)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- a multicenter, double-blind, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium adolescentis group | Experimental | Dietary Supplement: Bifidobacterium adolescentisBifidobacterium adolescentis supplementation |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium adolescentisSupplement with Bifidobacterium adolescentis twice/day in morning and tonight for 6 months | Dietary supplement | Bifidobacterium adolescentis group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
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.
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
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
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.
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
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
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
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.
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
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
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.
4 secondary outcomes
Flora Clock
Time frame: 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 Medical Outcomes Study Short Form 36(SF-36)
Time frame: Change from Baseline score at 6 months
Pittsburgh sleep quality index
Time frame: Change from Baseline score at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
liangjing wang, doctor study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium adolescentis in people with Healthy Adults (45-65 Years), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liangjing wang, doctor (+86 0571 87783759, wangljzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aging Ai 3.0 (time frame: Change from Baseline physiological age calculated by Aging Ai 3.0 at 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.