Monoclonal Gammopathy of Undetermined SignificanceKORMED-PA StudNCT07305662
Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS/SMM: A Pilot Study
A study testing KORMED Diet and Physical Activity Monitoring in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Myeloma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma
- What is being tested?
- KORMED Diet and Physical Activity Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Su Min Lee, +82-031-787-8801, si2176459@gmail.com
About this 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:
Read more
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?
- Being tested
- KORMED Diet and Physical Activity Monitoring
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KORMED Diet and Physical Activity MonitoringBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| KORMED Diet and Physical Activity Monitoring | Experimental | 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. Receives: Behavioral: KORMED Diet and Physical Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in K-MEDAS Score From Baseline to 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.
Measured: Baseline, 12 weeks
Secondary outcomes (3)
Change in Body Mass Index (BMI) From Baseline to 52 Weeks
BMI (kg/m²) will be measured to evaluate changes in body composition during and after the dietary intervention.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks
Serum M-protein will be quantified to explore potential effects of lifestyle intervention on clonal plasma cell activity.
Measured: 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
Thsese will be measured to evaluate inflammatory response to the intervention.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start30 Jan 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Mee Bang, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305662
- Sponsor's protocol ID
- B-2512-1017-002
- Acronym
- KORMED-PA Stud
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) due to privacy considerations and institutional restrictions. Only aggregated results will be shared in publications
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS/SMM: A Pilot Study
- ClinicalTrials.gov ID
- NCT07305662
- Acronym / sponsor ID
- KORMED-PA Stud / B-2512-1017-002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KORMED Diet and Physical Activity Monitoring | Experimental | Behavioral: KORMED Diet and Physical Activity MonitoringParticipants 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KORMED Diet and Physical Activity Monitoring1. 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. | Behavioural | KORMED Diet and Physical Activity Monitoring |
Primary outcome
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.
3 secondary outcomes
Change in Body Mass Index (BMI) From Baseline to 52 Weeks
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks
Time frame: 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
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) due to privacy considerations and institutional restrictions. Only aggregated results will be shared in publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KORMED Diet and Physical Activity Monitoring in people with Monoclonal Gammopathy of Undetermined Significance and Smoldering Myeloma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo-Mee Bang, MD, PhD (+82-31-787-7039, smbang7@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in K-MEDAS Score From Baseline to 12 Weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.