Dietary Habits, Healthy
Conditions
Keywords
Pilot randomized crossover feasibility trial, Plant-based diet, High-sensitivity C-reactive protein, Culture-tailored, Dietary behavior intervention
Brief 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.
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.
Interventions
OTHERGeneral 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.
OTHERPlant-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.
Sponsors
Tzu Chi University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Two sequence groups were established: participants were randomly allocated to group PBD (Plant-based diet)-GD (General diet) or group GD-PBD at a 1:1 ratio using a computer-generated random number sequence. A one-week washout period was implemented between stages to minimize carryover effects. 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 followed the reverse sequence.
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate (%) | At week 0 and week 5 | The number of participants included in the final analysis divided by the total number of participants enrolled |
| Meal Delivery Completion Rate (%) | 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 |
| Satisfaction score (mean score) | 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 |
| Adverse Events (event count) | Throughout the intervention periond, from week 1 to week 5 | Particular attention to food safety and the individual tolerability of the dietary changes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-sensitivity C-reactive protein (Hs-CRP, mg/L) | Before and After each Stage, at Week 1, 2, 4, and 5 | Physiological Inflammatory Indicator |
| Interleukin-6 (IL-6, pg/mL) | Before and After each Stage, at Week 1, 2, 4, and 5 | Physiological Pro-Inflammatory Indicator |
| Interleukin-10 (IL-10, pg/mL) | Before and After each Stage, at Week 1, 2, 4, and 5 | Physiological Anti-Inflammatory Indicator |
Countries
Taiwan
Contacts
STUDY_DIRECTORHui-Chun Chung, PhD
Assistant Professor, School of Nursing, Tzu Chi University
Outcome results
None listed