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

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: Not yet recruiting
• Conditions: Healthy Adults (45-65 Years)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Bifidobacterium adolescentis

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flora Clock	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	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)	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	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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2024
• Primary Completion (ANTICIPATED): July 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (ACTUAL): November 2, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID 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