Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS/SMM: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in K-MEDAS Score From Baseline to 12 Weeks
研究概览
简要总结
This single-arm pilot study aims to evaluate the feasibility and potential health effects of a Korean-style Mediterranean diet (KORMED) and continuous physical activity measurement in patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The study investigates whether a 12-week KORMED dietary intervention, combined with monitoring of daily step counts using a wearable device, can improve metabolic and inflammatory biomarkers, body composition, gut microbiome diversity, and quality of life.
The study seeks to answer the following primary question:
Is the KORMED diet feasible and achievable for MGUS/SMM patients, as measured by changes in K-MEDAS adherence scores over 12 weeks?
Secondary questions include:
- Does adherence to KORMED lead to improvements in BMI, inflammatory markers (CRP, IL-6), metabolic indicators (HOMA-IR, FLI), M-protein levels, and gut microbiome diversity?
- Is increased daily physical activity, measured by step counts, associated with favorable changes in metabolic and clinical parameters?
- Can combined dietary and activity-based lifestyle modification provide preliminary evidence supporting delayed disease progression in precursor plasma cell disorders?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following:
- •Adults aged 19 to 80 years at the time of enrollment.
- •Diagnosed with MGUS (Monoclonal Gammopathy of Undetermined Significance) or Smoldering Multiple Myeloma (SMM) according to standard criteria.
- •Able and willing to follow a Korean-style Mediterranean diet (KORMED) for 12 weeks.
- •Able to use a smartphone and wearable device to track daily physical activity.
- •Willing to attend study visits and provide blood, stool, and questionnaire data at scheduled time points.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Participants will not be eligible if they meet any of the following:
- •Diagnosis of active multiple myeloma requiring treatment.
- •Current participation in another interventional clinical trial.
- •Severe liver, kidney, or heart disease that would make the diet or study procedures unsafe.
- •Uncontrolled infection or serious medical condition that may interfere with participation.
- •History of major gastrointestinal surgery that prevents adherence to the diet.
- •Pregnant or breastfeeding, or planning to become pregnant during the study period.
- •Allergy or intolerance to key components of the KORMED diet (e.g., fish, nuts, legumes) that prevents safe participation.
- •Any condition, in the investigator's judgment, that would make participation unsafe or limit the ability to complete the study.
结局指标
主要结局
Change in K-MEDAS Score From Baseline to 12 Weeks
时间窗: Baseline, 12 weeks
The primary outcome is the change in adherence to the Korean-style Mediterranean diet measured using the validated K-MEDAS questionnaire. Higher scores indicate greater diet adherence. The mean change from baseline to week 12 will be assessed.
次要结局
- Change in Body Mass Index (BMI) From Baseline to 52 Weeks(Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks)
- Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Change in C-Reactive Protein (CRP), Interleukin-6 (IL-6), HOMA-IR (Insulin Resistance Index), and Fatty Liver Index (FLI) From Baseline to 52 Weeks(Baseline, 12 weeks, 24 weeks, 52 weeks)
研究者
Soo-Mee Bang
Professor
Seoul National University Bundang Hospital