A Culture-tailored Plant-based Dietary Intervention in Taiwan (NCT07728877) | Clinical Trial Compass
CompletedNot Applicable
A Culture-tailored Plant-based Dietary Intervention in Taiwan
Taiwan30 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
20 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Geneally halthy adults who followed an omnivorous diet
. Willing to adhere to the study interventions
Exclusion criteria
. Current treatment for diabetes, cancer, or immune disorders requiring dietary restrictions
. Participation in any dietary or exercise program within the previous 6 months
. Antibiotic therapy, non-steroidal anti-inflammatory drug use, or any surgery within the previous 3 months
. Shift work
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retention rate (%)
Timeframe: At week 0 and week 5
2
Meal Delivery Completion Rate (%)
Timeframe: Period of Meal Provision, at week 1-2 and week 4-5
3
Satisfaction score (mean score)
Timeframe: At each post-stage timepoint, week 2 and week 5
4
Adverse Events (event count)
Timeframe: Throughout the intervention periond, from week 1 to week 5