Plant-based Diets and Healthy Aging (TCAS)

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Chiayi
      • Dalin, Chiayi, Taiwan, 622
        • Recruiting
        • Dalin Tzu Chi Hospital.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hsueh-Ting Chiu, PhD, National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 17, 2025

First Submitted That Met QC Criteria

September 1, 2025

First Posted (Actual)

September 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

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

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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