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.
Inclusion Criteria:
Exclusion Criteria:
Full participant blinding was not possible given the nature of dietary interventions, and this represents an inherent limitation of dietary crossover designs; only laboratory personnel were blinded to group allocation and intervention stage.
Group PBD-GD completed the 2-week PBD stage first, crossed over after the washout period, then completed the 2-week GD stage.
Group GD-PBD completed the 2-week GD stage first, crossed over after the washout period, then completed the 2-week PBD stage
Hualien City, Taiwan
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