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Completed

NCT Number: NCT07728877

A Culture-tailored Plant-based Dietary Intervention in Taiwan

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.

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Key information

Conditions

Healthy Behavior Behavior, Animal Dietary Habits Feeding Behavior

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Amed Forces General hospital

Hualien City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Habitual consumption of probiotics or fermented dairy products in daily or occasional frequency
  • Habitual alcohol intake exceeding the recommended daily limits as 20 g for males and 10 g for females

Treatment and study plan

Plant-Based Diet

Other

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

Other

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.

Primary outcomes

  1. Retention rate (%)

    Time frame: At week 0 and week 5

    The number of participants included in the final analysis divided by the total number of participants enrolled

  2. Meal Delivery Completion Rate (%)

    Time frame: 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

  3. Satisfaction score (mean score)

    Time frame: 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

  4. Adverse Events (event count)

    Time frame: Throughout the intervention periond, from week 1 to week 5

    Particular attention to food safety and the individual tolerability of the dietary changes

Secondary outcomes

  1. High-sensitivity C-reactive protein (Hs-CRP, mg/L)

    Time frame: Before and After each Stage, at Week 1, 2, 4, and 5

    Physiological Inflammatory Indicator

  2. Interleukin-6 (IL-6, pg/mL)

    Time frame: Before and After each Stage, at Week 1, 2, 4, and 5

    Physiological Pro-Inflammatory Indicator

  3. Interleukin-10 (IL-10, pg/mL)

    Time frame: Before and After each Stage, at Week 1, 2, 4, and 5

    Physiological Anti-Inflammatory Indicator

Other outcomes

  1. Complete Blood Counts

    Time frame: Before and After each Stage, at Week 1, 2, 4, and 5

    WBC (10³/µL), RBC(10³/µL), Hgb (g/dL), HCT (%), and PLT (10³/µL)

  2. Fasting blood sugar (FBS, mg/dL) and Lipo-Profiles

    Time frame: Before and After each Stage, at Week 1, 2, 4, and 5

    Fasting blood sugar (FBS, mg/dL) and lipid profiles, including high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), and triglycerides (TG, mg/dL)

Sponsors and collaborators

Lead sponsor

Tzu Chi University

Other

Registry information

Official study title

A Culture-tailored Plant-based Dietary Intervention in Taiwan: A Pilot Randomized Crossover Feasibility Trial With Preliminary Inflammatory and Metabolic Outcomes

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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