Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma
Conditions
Brief summary
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: 1. 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? 2. Is increased daily physical activity, measured by step counts, associated with favorable changes in metabolic and clinical parameters? 3. Can combined dietary and activity-based lifestyle modification provide preliminary evidence supporting delayed disease progression in precursor plasma cell disorders?
Interventions
BEHAVIORALKORMED Diet and Physical Activity Monitoring
1. KORMED Diet (Dietary Intervention) Participants will follow a Korean-style Mediterranean diet for 12 weeks. The intervention emphasizes increased intake of vegetables, fruits, legumes, whole grains, seafood, nuts, and healthy plant oils while limiting refined carbohydrates, red and processed meats, and sugar-sweetened foods. Participants receive structured dietary counseling at baseline, week 6, and week 12, with remote guidance to support adherence throughout the intervention period. 2. Physical Activity Monitoring (Behavioral Intervention) Participants will wear an activity-tracking device throughout the 12-week intervention and subsequent follow-up. The device records daily step counts and physical activity patterns. Participants are encouraged to maintain or gradually increase daily activity, and step count feedback is reviewed during structured visits.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in K-MEDAS Score From Baseline to 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) From Baseline to 52 Weeks | Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks | BMI (kg/m²) will be measured to evaluate changes in body composition during and after the dietary intervention. |
| Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks | Baseline, 12 weeks, 24 weeks, 52 weeks | Serum M-protein will be quantified to explore potential effects of lifestyle intervention on clonal plasma cell activity. |
| 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 | Thsese will be measured to evaluate inflammatory response to the intervention. |
Countries
South Korea
Contacts
CONTACTSoo-Mee Bang, MD, PhD
Outcome results
None listed