NCT07151365

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

August 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 8, 2026

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

August 17, 2025

Last Update Submit

April 6, 2026

Conditions

Keywords

Vegetarian dietsPlant-based dietsHealthy agingCognitive declineSarcopeniaFrailty

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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).

    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).

    From baseline to three-year follow-up, six-year follow-up

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age 40 years or older.
  • Volunteers of the Tzu Chi Foundation.
  • Participating in the 2-day comprehensive health examination program.

You may not qualify if:

  • Pregnant individual.
  • Diagnosed with dementia or poor cognition resulting in inability to answer questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi Hospital.

Dalin, Chiayi, 622, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

SarcopeniaFrailtyCognitive Dysfunction

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic ProcessesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Hsueh-Ting Chiu, PhD

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh-Ting Chiu, PhD

CONTACT

Wen-Ling Lin, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 8, 2026

Record last verified: 2025-09

Locations