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NCT Number: NCT07414680

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Chang Gung Memorial Hospital, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The brain volume of local Taiwanese aged over 40 years old

    Time frame: one hour

    Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging

Secondary outcomes

  1. The actigraphy of local Taiwanese aged over 40 years old

    Time frame: two weeks

    Measure the circadian rhythm (unit in minute) by Actiwatch

  2. The sleep quality questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the sleep quality (unit in score) by Pittsburgh Sleep Quality Index (PSQI, Score range: 0 ~ 21, higher is worse)

  3. The gut microbiota of local Taiwanese aged over 40 years old

    Time frame: one day

    Fecal samples were analyzed using 16s full length rRNA gene sequencing to characterize the composition and diversity of the gut microbiota

  4. The metabolism of local Taiwanese aged over 40 years old

    Time frame: one day

    Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of blood samples, with metabolite concentrations quantified in mg/dL, respectively

  5. The metabolism of local Taiwanese aged over 40 years old

    Time frame: one day

    Nuclear Magnetic Resonance (NMR) spectroscopy was employed to perform metabolic profiling of urine samples, with metabolite concentrations quantified in mM, respectively

  6. The sleep quality questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the sleep quality (unit in score) by Stop-Bang Questionnaire (Score range: 0 ~ 8, higher is worse)

  7. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Mini-Mental State Examination Score (MMSE, Score range: 0 ~ 30, higher is better)

  8. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Geriatric Depression Scale (GDS, Score range: 0 ~ 15, higher is worse)

  9. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Short Physical Performance Battery Score (SPPB, Score range: 0 ~ 12, higher is better)

  10. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Clinical Frailty Scale (CFS, Score range: 1 ~ 9, higher is worse)

  11. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Apathy Evaluation Scale (AES, Score range: 18 ~ 72, higher is worse)

  12. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Connor-Davidson Resilience Scale (CD-RISC2, Score range: 0 ~ 8, higher is better)

  13. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by UCLA Loneliness Scale (UCLA, Score range: 20 ~ 80, higher is worse)

  14. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    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)

  15. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Hamilton Anxiety Rating Scale (HAM-A, Score range: 0 ~ 56, higher is worse)

  16. The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old

    Time frame: one day

    Measure the mental/neurocognitive condition (unit in score) by Hamilton Depression Rating Scale (HAM-D, Score range: 0 ~ 56, higher is worse)

Study contacts

Contact information is provided by the study sponsor or research team.

JI-TSENG FANG, Professor

CONTACT

[email protected]

+886-3-3281200

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Chang Gung University

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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