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HealthyNCT07728877

A Culture-tailored Plant-based Dietary Intervention in Taiwan

A study testing Plant-Based Diet and General Diet in people with Healthy and Dietary Habits, run by Tzu Chi University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Dietary Habits
What is being tested?
Plant-Based Diet and General Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Jun 2023to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Geneally halthy adults who followed an omnivorous diet
  • Willing to adhere to the study interventions

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Hualien Amed Forces General hospital

    Hualien City

Other trials in Taiwan

About this study

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

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?

Read more

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.

Read the 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.

Being tested
Plant-Based Diet, General Diet
Keywords
Pilot randomized crossover feasibility trial, Plant-based diet, High-sensitivity C-reactive protein, Culture-tailored, Dietary behavior intervention
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plant-Based DietOther

    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 DietOther

    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.

Study groups in NCT07728877
Study groupRoleWhat they receive
Group PBD-GDExperimentalGroup PBD-GD completed the 2-week PBD stage first, crossed over after the washout period, then completed the 2-week GD stage.
Receives: Other: Plant-Based Diet; Other: General Diet
Group GD-PBDExperimentalGroup GD-PBD completed the 2-week GD stage first, crossed over after the washout period, then completed the 2-week PBD stage
Receives: Other: Plant-Based Diet; Other: General Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention rate (%)

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

    Measured: At week 0 and week 5

  2. Meal Delivery Completion Rate (%)

    The number of meal deliveries received within the designated time window divided by the total number of scheduled meal deliveries across the intervention period

    Measured: Period of Meal Provision, at week 1-2 and week 4-5

  3. Satisfaction score (mean score)

    A score of 3.0 of each item on a 5-point Likert scale was utilized as the minimal criterion for acceptability

    Measured: At each post-stage timepoint, week 2 and week 5

  4. Adverse Events (event count)

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

    Measured: Throughout the intervention periond, from week 1 to week 5

Secondary outcomes (3)
  1. High-sensitivity C-reactive protein (Hs-CRP, mg/L)

    Physiological Inflammatory Indicator

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

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

    Physiological Pro-Inflammatory Indicator

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

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

    Physiological Anti-Inflammatory Indicator

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start1 Jun 2023
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728877
Sponsor's protocol ID
IRB111-208-B
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Christ A, Lauterbach M, Latz E. Western Diet and the Immune System: An Inflammatory Connection. Immunity. 2019 Nov 19;51(5):794-811. doi: 10.1016/j.immuni.2019.09.020.

    PubMed 31747581
  • Leitzmann C. Vegetarian nutrition: past, present, future. Am J Clin Nutr. 2014 Jul;100 Suppl 1:496S-502S. doi: 10.3945/ajcn.113.071365. Epub 2014 Jun 4.

    PubMed 24898226
  • Wang T, Masedunskas A, Willett WC, Fontana L. Vegetarian and vegan diets: benefits and drawbacks. Eur Heart J. 2023 Sep 21;44(36):3423-3439. doi: 10.1093/eurheartj/ehad436.

    PubMed 37450568
  • Ciaffi J, Mancarella L, Ripamonti C, Brusi V, Pignatti F, Lisi L, Ursini F. Ultra-Processed Food Consumption and Systemic Inflammatory Biomarkers: A Scoping Review. Nutrients. 2025 Sep 20;17(18):3012. doi: 10.3390/nu17183012.

    PubMed 41010537
  • Akanyibah FA, He C, Wang X, Wang B, Mao F. The role of plant-based dietary compounds in gut microbiota modulation in inflammatory bowel disease. Front Nutr. 2025 May 30;12:1606289. doi: 10.3389/fnut.2025.1606289. eCollection 2025.

    PubMed 40521353
  • Wang X, Wong K, Ouyang W, Rutz S. Targeting IL-10 Family Cytokines for the Treatment of Human Diseases. Cold Spring Harb Perspect Biol. 2019 Feb 1;11(2):a028548. doi: 10.1101/cshperspect.a028548.

    PubMed 29038121
  • Moore DM, Madrid I, Lindsay KL. Systematic Review of Easy-to-Learn Behavioral Interventions for Dietary Changes Among Young Adults. J Nutr Educ Behav. 2023 Jul;55(7):509-522. doi: 10.1016/j.jneb.2023.04.001. Epub 2023 May 10.

    PubMed 37162435
  • Menzel J, Jabakhanji A, Biemann R, Mai K, Abraham K, Weikert C. Systematic review and meta-analysis of the associations of vegan and vegetarian diets with inflammatory biomarkers. Sci Rep. 2020 Dec 10;10(1):21736. doi: 10.1038/s41598-020-78426-8.

    PubMed 33303765
  • Rong YD, Bian AL, Hu HY, Ma Y, Zhou XZ. Study on relationship between elderly sarcopenia and inflammatory cytokine IL-6, anti-inflammatory cytokine IL-10. BMC Geriatr. 2018 Dec 12;18(1):308. doi: 10.1186/s12877-018-1007-9.

    PubMed 30541467
  • Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.

    PubMed 11392867
  • Lv J, Hao P, Zhou Y, Liu T, Wang L, Song C, Wang Z, Liu Z, Liu Y. Role of the intestinal flora-immunity axis in the pathogenesis of rheumatoid arthritis-mechanisms regulating short-chain fatty acids and Th17/Treg homeostasis. Mol Biol Rep. 2025 Jun 21;52(1):617. doi: 10.1007/s11033-025-10714-w.

    PubMed 40544212
  • Nilsson A, Cano A, Bergens O, Kadi F. Randomized Controlled Trial for Promotion of Healthy Eating in Older Adults by Increasing Consumption of Plant-Based Foods: Effect on Inflammatory Biomarkers. Nutrients. 2021 Oct 24;13(11):3753. doi: 10.3390/nu13113753.

    PubMed 34836009
  • Coumans JMJ, Bolman CAW, Oenema A, Lechner L. Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial. J Med Internet Res. 2020 Jul 23;22(7):e15024. doi: 10.2196/15024.

    PubMed 32706659
  • Gibbs J, Cappuccio FP. Plant-Based Dietary Patterns for Human and Planetary Health. Nutrients. 2022 Apr 13;14(8):1614. doi: 10.3390/nu14081614.

    PubMed 35458176
  • Dong H, Zhang Y, Huang Y, Deng H. Pathophysiology of RAGE in inflammatory diseases. Front Immunol. 2022 Jul 29;13:931473. doi: 10.3389/fimmu.2022.931473. eCollection 2022.

    PubMed 35967420

Questions about this trial

What is this clinical trial studying?

A study testing Plant-Based Diet and General Diet in people with Healthy and Dietary Habits, run by Tzu Chi University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention rate (%) (time frame: At week 0 and week 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728877, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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