- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07151365
- Original Trial
Plant-based Diets and Healthy Aging (TCAS)
Plant-based Diets and Healthy Aging - the Tzu Chi Aging Study (TCAS)
Study Overview
Status
Conditions
Detailed Description
This study establishes a new cohort to investigate the role of vegetarian and plant-based diets in healthy aging, integrating functional, nutritional, and genetic data. The primary objective is to clarify how dietary patterns and nutrient intake influence aging-related health conditions, including sarcopenia, cognitive function, physical function, and psychological well-being, and investigate how the associations between diet and these health conditions may be modified by genetic risk factors.
Participants are Tzu Chi volunteers aged 40 years and older who undergo comprehensive health evaluations at Dalin Tzu Chi Hospital every three years. This population consists of a uniquely high proportion of vegetarians, non-smoking non-alcohol drinking individuals, and older adults who are active in communities and social engagement and community services; providing a unique opportunity to examine the role of plant-based diets and community services on aging related conditions without confounding by smoking and alcohol. Diet data are collected through a previously validated food frequency questionnaire, a short newly developed questionnaire - Taiwan Diet Quality Calculator - that will be validated within a subcohort of the current study, and food diaries for participants who are willing to provide such details. Nutritional biomarkers (e.g., serum vitamin B12, vitamin D, skin carotenoids), along with routine health examination values (complete blood counts, lipid profiles, renal and liver functions, bone mineral density) will also be collected. When funding permits, genome-wide genotyping, metabolomics, and other aging-related biomarkers will also be examined.
For cohort follow-up, study participants will be invited back for follow-up health examination every three years. In addition, data will also be linked to National Health Insurance Claim database, National Cancer registry, and National Mortality Registry in Taiwan to further ascertain relevant health outcomes.
By integrating comprehensive dietary assessments, nutritional biomarkers, health examination and genetic data, and aging-related functional outcomes, this cohort will provide an unique opportunity to examine dietary patterns, nutrient requirements, and lifestyle that best support healthy aging. The inclusion of genomic and metabolomic analyses will further enable the investigation of diet-gene interactions, supporting the development of precision nutrition strategies for individuals at elevated genetic risk. This research is expected to inform strategies for disease prevention and the maintenance of functional independence in older adults.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hsueh-Ting Chiu, PhD
- Phone Number: 27 +886-5-6325080
- Email: tinachiu@nhri.edu.tw
Study Contact Backup
- Name: Wen-Ling Lin, PhD
- Phone Number: 29 +886-5-6325080
- Email: wenling926@nhri.edu.tw
Study Locations
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Chiayi
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Dalin, Chiayi, Taiwan, 622
- Recruiting
- Dalin Tzu Chi Hospital.
-
Contact:
- Hsueh-Ting Chiu, phd
- Phone Number: +886-5-6325080#27
- Email: tinachiu@nhri.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 40 years or older.
- Volunteers of the Tzu Chi Foundation.
- Participating in the 2-day comprehensive health examination program.
Exclusion Criteria:
- Pregnant individual.
- Diagnosed with dementia or poor cognition resulting in inability to answer questionnaires.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function
Time Frame: From enrollment to three-year follow-up, six-year follow up
|
Cognitive function will be assessed using Montreal Cognitive Assessment [MoCA], Taiwanese version.
(Score range 0-30, unit = points).
A score ≥26 is generally considered normal, while scores <26 suggest possible cognitive impairment.
Outcomes will be reported both as continuous MoCA scores and as a binary classification (normal vs. impaired).
|
From enrollment to three-year follow-up, six-year follow up
|
|
Appendicular skeletal muscle mass
Time Frame: From baseline to three-year follow-up, six-year follow-up
|
Appendicular skeletal muscle mass (ASM) will be assessed by bioimpedance analysis (BIA), with height-adjusted cutoffs of <7.0 kg/m² in men and <5.7 kg/m² in women defined as low ASM.
Results will be reported as both continuous measures (kg/m²) and categorical measures (normal or low ASM).
|
From baseline to three-year follow-up, six-year follow-up
|
|
Grip strength
Time Frame: From baseline to three-year follow-up, six-year follow-up
|
Grip strength will be assessed using a handheld dynamometer, with cutoffs defined as <28 kg for men and <18 kg for women.
Results will be reported as continuous measures (kg).
|
From baseline to three-year follow-up, six-year follow-up
|
|
Sarcopenia
Time Frame: From baseline to three-year follow-up, six-year follow-up
|
Sarcopenia will be defined as the combined presence of low ASM and low grip strength.
Results will be reported as a binary outcome (yes/no).
|
From baseline to three-year follow-up, six-year follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hsueh-Ting Chiu, PhD, National Health Research Institutes, Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Mental Disorders
- Pathologic Processes
- Pathological Conditions, Anatomical
- Neurocognitive Disorders
- Cognition Disorders
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Frailty
- Cognitive Dysfunction
- Sarcopenia
Other Study ID Numbers
- EC1131206
- IRB Approval Number (Other Identifier: WMC/ERC/IRB/157)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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