A Culture-tailored Plant-based Dietary Intervention in Taiwan

July 23, 2026 updated by: Hui-Hsin Lin, Tzu Chi University

A Culture-tailored Plant-based Dietary Intervention in Taiwan: A Pilot Randomized Crossover Feasibility Trial With Preliminary Inflammatory and Metabolic Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Despite growing evidence for PBD's anti-inflammatory effects, few studies have examined its feasibility and short-term efficacy within a culturally specific, real-world dietary context, particularly in East Asian populations. The current pilot randomized crossover feasibility trial aimed to determine the feasibility of a short-term, culture-tailored, and plant-based dietary behavior intervention and its preliminary outcomes regarding inflammation and metabolic markers.

Methods The randomized, single-blinded crossover feasibility trial was conducted at a regional general hospital in eastern Taiwan. Participants were randomly allocated to group PBD-GD or group GD-PBD using a computer-generated random number sequence. After 2-week intervention followed by 1-week washout period, participants were crossed over to the other group for the subsequent 2-week intervention. During the dietary intervention, lunch and dinner were provided by local commercial restaurants during weekdays based on assigned stage. Primary outcome, high-sensitivity C-reactive protein (Hs-CRP), along with the secondary outcomes, interleukin-6 (IL-6), IL-10, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and triglycerides (TG) were measured before and after each intervention, at week 0, 2, 3, and 4. Adherence was supported through two platforms, an anonymous group messaging platform and a mobile food diary application.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Hualien City, Taiwan
        • Hualien Amed Forces General hospital

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Geneally halthy adults who followed an omnivorous diet
  2. Willing to adhere to the study interventions

Exclusion Criteria:

  1. Current treatment for diabetes, cancer, or immune disorders requiring dietary restrictions
  2. Participation in any dietary or exercise program within the previous 6 months
  3. Antibiotic therapy, non-steroidal anti-inflammatory drug use, or any surgery within the previous 3 months
  4. Shift work
  5. Habitual consumption of probiotics or fermented dairy products in daily or occasional frequency
  6. Habitual alcohol intake exceeding the recommended daily limits as 20 g for males and 10 g for females

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group PBD-GD
Group PBD-GD completed the 2-week PBD stage first, crossed over after the washout period, then completed the 2-week GD stage.
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.
Experimental: Group GD-PBD
Group GD-PBD completed the 2-week GD stage first, crossed over after the washout period, then completed the 2-week PBD stage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate (%)
Time Frame: At week 0 and week 5
The number of participants included in the final analysis divided by the total number of participants enrolled
At week 0 and week 5
Meal Delivery Completion Rate (%)
Time Frame: Period of Meal Provision, at week 1-2 and week 4-5
The number of meal deliveries received within the designated time window divided by the total number of scheduled meal deliveries across the intervention period
Period of Meal Provision, at week 1-2 and week 4-5
Satisfaction score (mean score)
Time Frame: At each post-stage timepoint, week 2 and week 5
A score of 3.0 of each item on a 5-point Likert scale was utilized as the minimal criterion for acceptability
At each post-stage timepoint, week 2 and week 5
Adverse Events (event count)
Time Frame: Throughout the intervention periond, from week 1 to week 5
Particular attention to food safety and the individual tolerability of the dietary changes
Throughout the intervention periond, from week 1 to week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-sensitivity C-reactive protein (Hs-CRP, mg/L)
Time Frame: Before and After each Stage, at Week 1, 2, 4, and 5
Physiological Inflammatory Indicator
Before and After each Stage, at Week 1, 2, 4, and 5
Interleukin-6 (IL-6, pg/mL)
Time Frame: Before and After each Stage, at Week 1, 2, 4, and 5
Physiological Pro-Inflammatory Indicator
Before and After each Stage, at Week 1, 2, 4, and 5
Interleukin-10 (IL-10, pg/mL)
Time Frame: Before and After each Stage, at Week 1, 2, 4, and 5
Physiological Anti-Inflammatory Indicator
Before and After each Stage, at Week 1, 2, 4, and 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Blood Counts
Time Frame: Before and After each Stage, at Week 1, 2, 4, and 5
WBC (10³/µL), RBC(10³/µL), Hgb (g/dL), HCT (%), and PLT (10³/µL)
Before and After each Stage, at Week 1, 2, 4, and 5
Fasting blood sugar (FBS, mg/dL) and Lipo-Profiles
Time Frame: Before and After each Stage, at Week 1, 2, 4, and 5
Fasting blood sugar (FBS, mg/dL) and lipid profiles, including high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), and triglycerides (TG, mg/dL)
Before and After each Stage, at Week 1, 2, 4, and 5

Collaborators and Investigators

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

Sponsor

Tzu Chi University

Investigators

  • Study Director: Hui-Chun Chung, PhD, Assistant Professor, School of Nursing, Tzu Chi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB111-208-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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