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A Culture-tailored Plant-based Dietary Intervention in Taiwan
Sponsor: Tzu Chi University
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.
Official title: A Culture-tailored Plant-based Dietary Intervention in Taiwan: A Pilot Randomized Crossover Feasibility Trial With Preliminary Inflammatory and Metabolic Outcomes
Key Details
Gender
All
Age Range
20 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-06-01
Completion Date
2023-09-30
Last Updated
2026-07-27
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Hualien Amed Forces General hospital
Hualien City, Taiwan