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NCT Number: NCT07305662

Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS/SMM: A Pilot Study

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?

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Key information

Conditions

Monoclonal Gammopathy of Undetermined Significance Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Neoplasms Paraproteinemias Precancerous Conditions Smoldering Multiple Myeloma Smoldering Myeloma

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

KORMED Diet and Physical Activity Monitoring

Behavioral
  • 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.
  • 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.

Primary outcomes

  1. Change in K-MEDAS Score From Baseline to 12 Weeks

    Time frame: 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 outcomes

  1. Change in Body Mass Index (BMI) From Baseline to 52 Weeks

    Time frame: 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.

  2. Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks

    Time frame: 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.

  3. 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

    Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks

    Thsese will be measured to evaluate inflammatory response to the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Soo-Mee Bang, MD, PhD

CONTACT

[email protected]

+82-31-787-7039

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Acronym: KORMED-PA Stud

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Jan 21, 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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