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

Seoul National University

Status: Not yet enrolling

Conditions: Smoldering Myeloma; Monoclonal Gammopathy of Undetermined Significance

Treatments: Behavioral: KORMED Diet and Physical Activity Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07305662

B-2512-1017-002

Details and patient eligibility

About

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?

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

KORMED Diet and Physical Activity Monitoring

Experimental group

Description:

Participants in this single-arm study will receive a 12-week Korean-style Mediterranean diet (KORMED) intervention designed to increase consumption of vegetables, fruits, whole grains, fish, legumes, and healthy oils while limiting refined carbohydrates and red or processed meats. Participants will also undergo continuous physical activity monitoring using a wearable device to measure daily step counts throughout the intervention and follow-up period. Nutritional counseling will be provided at scheduled visits (baseline, 6 weeks, and 12 weeks), and remote check-ins will support adherence. After the 12-week intervention, participants will be followed through 52 weeks to assess changes in diet adherence, physical activity, metabolic and inflammatory biomarkers, gut microbiome diversity, and quality-of-life outcomes.

Treatment:

Behavioral: KORMED Diet and Physical Activity Monitoring