A Culture-tailored Plant-based Dietary Intervention in Taiwan: A Pilot Randomized Crossover Feasibility Trial With Preliminary Inflammatory and Metabolic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rate (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Geneally halthy adults who followed an omnivorous diet
- •Willing to adhere to the study interventions
排除标准
- •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
- •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
结局指标
主要结局
Retention rate (%)
时间窗: 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 (%)
时间窗: 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)
时间窗: 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)
时间窗: Throughout the intervention periond, from week 1 to week 5
Particular attention to food safety and the individual tolerability of the dietary changes
次要结局
- High-sensitivity C-reactive protein (Hs-CRP, mg/L)(Before and After each Stage, at Week 1, 2, 4, and 5)
- Interleukin-6 (IL-6, pg/mL)(Before and After each Stage, at Week 1, 2, 4, and 5)
- Interleukin-10 (IL-10, pg/mL)(Before and After each Stage, at Week 1, 2, 4, and 5)
研究者
Hui-Hsin Lin
Section Chief
Tri-Service General Hospital (TSGH)