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Completed
NCT07728877
A Culture-tailored Plant-based Dietary Intervention in Taiwan
Conditions: Healthy, Dietary Habits
Sex: All
Ages: 20 Years – 64 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Tzu Chi University
Location: Hualien Amed Forces General hospital Hualien City
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07728877). StuddyBuddy aggregates publicly available trial information.