Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4

This project aims to build up the comprehensive health database of geriatric medicine for middle-aged and elderly people in Taiwan.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Change; Sleep Disturbance; Aging

Detailed Description

This project aims to establish a comprehensive local health database for adults aged 40 and above by integrating clinical data, functional assessments, genomics, metabolomics, and gut microbiome profiles.

The project focuses on validating metabolomic and genetic biomarkers associated with sarcopenia and developing predictive models for early risk identification. Longitudinal multi-omics analyses will be conducted using blood, urine, and fecal samples to explore metabolic dynamics and their links to aging-related conditions. In parallel, the study examines brain health and psychosocial factors, including sleep, resilience, apathy, and loneliness, to better understand their roles in cognitive function and healthy aging.

Through the integration of large-scale health data and advanced analytical approaches, this project aims to support early detection, personalized intervention strategies, and the development of precision healthy aging models.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: JI-TSENG FANG, Professor; Phone Number: +886-3-3281200; Email: fangjits@cgmh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 105
    • Taipei Chang Gung Memorial Hospital
    • Contact: JI-TSENG FANG, Professor; Phone Number: +886-3-3281200; Email: fangjits@cgmh.org.tw
  • Taoyuan District, Taiwan, 333
    • Taoyuan Chang Gung Memorial Hospital
    • Contact: JI-TSENG FANG, Professor; Phone Number: +886-3-3281200; Email: fangjits@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

By collecting data from participants in the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrating Systemic Geriatric Medical Information to Explore Solutions for Healthy Aging" main project, and the "Integrating Systemic Medical Information to Explore Solutions for Healthy Aging" project, approximately 100 individuals aged 60 and above, residing in Songshan District of Taipei City, Chang Gung Health and Wellness Village, and Senior Citizens' Health Activity Centers (Shuanglian, New Taipei City; Delai, Taoyuan City), were included. Additionally, 100-150 middle-aged employees aged 40-59 from Chang Gung Hospital, Formosa Plastics Group, and Chang Gung University were also included.

Description

Inclusion Criteria:

• Willing to sign a written participant consent form.
• Males or females aged 40 or above who have participated in the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging" master planner, or the "Integrated Systematic Medical Information to Explore Solutions for Healthy Aging" project (not subject to exclusion criteria).
• Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University.
• Those with a medical record of more than one year at Chang Gung Memorial Hospital.
• Those who have resided in Taiwan for more than 180 days in the past year.

Exclusion Criteria:

• Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization/emergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment.
• Individuals with a history of severe autoimmune diseases.
• Individuals with a preliminary cognitive and mental assessment score of <26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS).
• Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia).
• Individuals who have taken antibiotics within the past month.
• Individuals whose hearing, vision, or cognitive impairments affect communication.
• Individuals unable to stand or walk (with a walking aid) or with unsteady gait when walking.
• Those who have undergone follow-up outpatient assessments that may affect cognitive function, including but not limited to stroke, Parkinson's syndrome, Parkinson's dementia, epilepsy, brain tumor, or a history of mental illness such as schizophrenia, severe depression, bipolar disorder, alcohol or drug abuse, or a history of loss of consciousness due to severe head trauma.
• Those currently diagnosed with depression and undergoing treatment.
• Those with a past medical history confirming dementia, depression, etc..
• Those deemed unsuitable by a physician.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The brain volume of local Taiwanese aged over 40 years old	Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging	one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The actigraphy of local Taiwanese aged over 40 years old	Measure the circadian rhythm (unit in minute) by Actiwatch	two weeks
The sleep quality questionnaire of local Taiwanese aged over 40 years old	Measure the sleep quality (unit in score) by Pittsburgh Sleep Quality Index (PSQI, Score range: 0 ~ 21, higher is worse)	one day
The gut microbiota of local Taiwanese aged over 40 years old	Fecal samples were analyzed using 16s full length rRNA gene sequencing to characterize the composition and diversity of the gut microbiota	one day
The metabolism of local Taiwanese aged over 40 years old	Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of blood samples, with metabolite concentrations quantified in mg/dL, respectively	one day
The metabolism of local Taiwanese aged over 40 years old	Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of urine samples, with metabolite concentrations quantified in mM, respectively	one day
The sleep quality questionnaire of local Taiwanese aged over 40 years old	Measure the sleep quality (unit in score) by Stop-Bang Questionnaire (Score range: 0 ~ 8, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Mini-Mental State Examination Score (MMSE, Score range: 0 ~ 30, higher is better)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Geriatric Depression Scale (GDS, Score range: 0 ~ 15, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Short Physical Performance Battery Score (SPPB, Score range: 0 ~ 12, higher is better)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Clinical Frailty Scale (CFS, Score range: 1 ~ 9, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Apathy Evaluation Scale (AES, Score range: 18 ~ 72, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Connor-Davidson Resilience Scale (CD-RISC2, Score range: 0 ~ 8, higher is better)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by UCLA Loneliness Scale (UCLA, Score range: 20 ~ 80, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB, Score range: 0 ~ 100, higher is better)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Hamilton Anxiety Rating Scale (HAM-A, Score range: 0 ~ 56, higher is worse)	one day
The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old	Measure the mental/neurocognitive condition (unit in score) by Hamilton Depression Rating Scale (HAM-D, Score range: 0 ~ 56, higher is worse)	one day

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: dementia; depression; brain structure; system biology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Sleep Wake Disorders; Behavior; Parasomnias; Depression; Dementia
• Other Study ID Numbers: 202501674B0A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No