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

NCT05603455 | Unknown

• 1 other identifier: 2022-LHZHZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults (45-65 Years)

Outcome Measures

Primary Outcomes (11)

• 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.

  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

  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

  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.

  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

  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

  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

  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.

  Change from Baseline Telomere level at 6 months

• Blood pressure

  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

  The higher the body fat percentage, the better the health status

  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.

  Change from Baseline the expression level of indicators at 6 months

Secondary Outcomes (4)

• Flora Clock

  Change from Baseline physiological age calculated by Flora Clock at 6 months

• Mini-Nutritional Assessment

  Change from Baseline score at 6 months

• The Medical Outcomes Study Short Form 36(SF-36)

  Change from Baseline score at 6 months

• Pittsburgh sleep quality index

  Change from Baseline score at 6 months

Study Arms (2)

Bifidobacterium adolescentis group

EXPERIMENTAL

Bifidobacterium adolescentis supplementation

Dietary Supplement: Bifidobacterium adolescentis

Placebo group

PLACEBO COMPARATOR

Placebo supplementation

Dietary Supplement: Placebo

Interventions

Bifidobacterium adolescentis DIETARY_SUPPLEMENT

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

Bifidobacterium adolescentis group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 317000, China

Location

Study Officials

• liangjing wang, doctor

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

  STUDY CHAIR

Central Study Contacts

liangjing wang, doctor

CONTACT

+86 0571 87783759; wangljzju@zju.edu.cn

chaochao xu, doctor

CONTACT

+86 0571 87783759; xucc0922@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding of both the investigator (except for the investigator responsible for blinded product allocation) and the subject
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a multicenter, double-blind, randomized, controlled study

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 2, 2022
• Study Start: January 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 9, 2023

Record last verified: 2022-10

Locations

CN (1)