Healthy AgingTCASNCT07151365
Plant-based Diets and Healthy Aging
An observational study of Healthy Aging and Sarcopenia, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This prospective study investigates the health effects of vegetarian and plant-based diets in middle-aged and older adults in Taiwan, specifically, recruiting 5000 Tzu Chi volunteers. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Sarcopenia, Frailty
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Middle-aged and older adults (≥40 years) who are volunteers of the Tzu Chi Foundation or their relatives and friends, participating in the 2-day comprehensive health examination program in Taiwan.
Who may be able to join
- Age 40 years or older.
- Volunteers of the Tzu Chi Foundation.
- Participating in the 2-day comprehensive health examination program.
Who cannot join
- Pregnant individual.
- Diagnosed with dementia or poor cognition resulting in inability to answer questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Dalin Tzu Chi Hospital.
Dalin, Chiayi, 622
Hsueh-Ting Chiu, phd, +886-5-6325080#27, tinachiu@nhri.edu.tw
About this study
Official title: Plant-based Diets and Healthy Aging - the Tzu Chi Aging Study (TCAS)
This prospective study investigates the health effects of vegetarian and plant-based diets in middle-aged and older adults in Taiwan, specifically, recruiting 5000 Tzu Chi volunteers. Previous Tzu Chi cohorts found vegetarian diets were protectively associated with incidences of diabetes, stroke, gout, cataracts, insomnia, and gallstones, while reducing healthcare costs. The study also aims to clarify dietary patterns-particularly plant-based and vegetarian diets-and determine how potential deficiencies or excesses of various nutrients influence common aging-related health issues, including healthy cognitive decline, sarcopenia, and the risk of age-related diseases, in order to inform dietary and lifestyle recommendations that promote healthy aging and maintain physical function.
Read the 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.
- Conditions
- Healthy Aging, Sarcopenia, Frailty, Cognitive Decline
- Keywords
- Vegetarian diets, Plant-based diets, Healthy aging, Cognitive decline, Sarcopenia, Frailty
- Medical subject headings
- Sarcopenia, Frailty, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
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).
Measured: From enrollment to three-year follow-up, six-year follow up
Appendicular skeletal muscle mass
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).
Measured: From baseline to three-year follow-up, six-year follow-up
Grip strength
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).
Measured: From baseline to three-year follow-up, six-year follow-up
Sarcopenia
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).
Measured: From baseline to three-year follow-up, six-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsueh-Ting Chiu, PhD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151365
- Sponsor's protocol ID
- EC1131206
- Other IDs
- IRB approval number
- Acronym
- TCAS
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant-based Diets and Healthy Aging - the Tzu Chi Aging Study (TCAS)
- ClinicalTrials.gov ID
- NCT07151365
- Acronym / sponsor ID
- TCAS / EC1131206
- Conditions
- Healthy Aging, Sarcopenia, Frailty, Cognitive Decline
- Keywords
- Vegetarian diets, Plant-based diets, Healthy aging, Cognitive decline, Sarcopenia, Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study investigates the health effects of vegetarian and plant-based diets in middle-aged and older adults in Taiwan, specifically, recruiting 5000 Tzu Chi volunteers. Previous Tzu Chi cohorts found vegetarian diets were protectively associated with incidences of diabetes, stroke, gout, cataracts, insomnia, and gallstones, while reducing healthcare costs. The study also aims to clarify dietary patterns-particularly plant-based and vegetarian diets-and determine how potential deficiencies or excesses of various nutrients influence common aging-related health issues, including healthy cognitive decline, sarcopenia, and the risk of age-related diseases, in order to inform dietary and lifestyle recommendations that promote healthy aging and maintain physical function.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Middle-aged and older adults (≥40 years) who are volunteers of the Tzu Chi Foundation or their relatives and friends, participating in the 2-day comprehensive health examination program in Taiwan.
Key inclusion criteria (3 listed)
- Age 40 years or older.
- Volunteers of the Tzu Chi Foundation.
- Participating in the 2-day comprehensive health examination program.
Key exclusion criteria (2 listed)
- Pregnant individual.
- Diagnosed with dementia or poor cognition resulting in inability to answer questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsueh-Ting Chiu, PhD principal investigator
National Health Research Institutes, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging and Sarcopenia, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsueh-Ting Chiu, PhD (+886-5-6325080 ext. 27, tinachiu@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: From enrollment to three-year follow-up, six-year follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.