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A Culture-tailored Plant-based Dietary Intervention in Taiwan

NCT07728877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-27

No results posted yet for this study

Summary

The goal of this pilot randomized crossover feasibility trial is to determine the feasibility of a short-term, culture-tailored, plant-based dietary behavior intervention and examine the preliminary outcomes regarding inflammation and metabolic markers in generally healthy adults. The main questions it aimed to answer were:

Are the trial design and corresponding outcomes, including recruitment rate, retention rate, meal delivery completion, participant satisfaction, and adverse event occurrence feasible for a future definitive study? Are the clinical outcomes were examined as preliminary secondary endpoints able to generate effect size estimates for future study planning?

Participants were:

Randomly allocated to group PBD (plant-based diet)-GD (general diet) or group GD-PBD. Group PBD-GD completed the 2-week PBD stage first, crossed over after the 1-week washout period, then completed the 2-week GD stage. Group GD-PBD followed the reverse sequence.

Instructed to record their daily dietary intake throughout both stages in a mobile food diary application.

Invited to visit the trial venue for the measurements at four time points: before and after each stage.

Conditions

  • Healthy
  • Dietary Habits

Interventions

OTHER

Plant-Based Diet

Lunch and dinner were provided on workdays according to the assigned dietary stage, as boxed takeout meals prepared by local restaurants or catering companies. Deliveries were scheduled to arrive at the study hospital between 12:00 and 12:30 for lunch and 17:00 and 17:30 for dinner. A research assistant was to coordinate and contact the local restaurants for meal delivery an hour before the planned schedule. Participants were instructed to collect their meals from the research office before 12:30 and 17:30, respectively.

OTHER

General Diet

Lunch and dinner were provided on workdays according to the assigned dietary stage, as boxed takeout meals prepared by local restaurants or catering companies. Deliveries were scheduled to arrive at the study hospital between 12:00 and 12:30 for lunch and 17:00 and 17:30 for dinner. A research assistant was to coordinate and contact the local restaurants for meal delivery an hour before the planned schedule. Participants were instructed to collect their meals from the research office before 12:30 and 17:30, respectively.

Sponsors & Collaborators

  • Tzu Chi University

    lead OTHER

Principal Investigators

  • Hui-Chun Chung, PhD · Assistant Professor, School of Nursing, Tzu Chi University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728877 on ClinicalTrials.gov