[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616442":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":19,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: KORMED Diet and Physical Activity Monitoring",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","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.\n2. 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.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Soo-Mee Bang, MD, PhD","CONTACT","+82-31-787-7039","smbang7@snu.ac.kr",[27],{"facility":5,"status":19,"city":28,"state":29,"zip":30,"country":31,"countryCode":19,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":33,"coordinates":34},"Point",[35,36],127.13778,37.43861,{"lat":36,"lon":35},[39],{"name":40,"role":23,"phone":41,"phoneExt":19,"email":42},"Su Min Lee","+82-031-787-8801","si2176459@gmail.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Soo-Mee Bang","Professor","100616442","exploring-the-effects-of-korean-style-mediterranean-diet-kormed-and-physical-activity-measurement-in-patients-with-mgussmm-a-pilot-study-100616442",false,"NCT07305662","Exploring the Effects of Korean-Style Mediterranean Diet (KORMED) and Physical Activity Measurement in Patients With MGUS\u002FSMM: A Pilot Study","KORMED-PA Stud","Inclusion Criteria:\n\nParticipants must meet all of the following:\n\nAdults aged 19 to 80 years at the time of enrollment.\n\nDiagnosed with MGUS (Monoclonal Gammopathy of Undetermined Significance) or Smoldering Multiple Myeloma (SMM) according to standard criteria.\n\nAble and willing to follow a Korean-style Mediterranean diet (KORMED) for 12 weeks.\n\nAble to use a smartphone and wearable device to track daily physical activity.\n\nWilling to attend study visits and provide blood, stool, and questionnaire data at scheduled time points.\n\nAble to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Participants will not be eligible if they meet any of the following:\n\nDiagnosis of active multiple myeloma requiring treatment.\n\nCurrent participation in another interventional clinical trial.\n\nSevere liver, kidney, or heart disease that would make the diet or study procedures unsafe.\n\nUncontrolled infection or serious medical condition that may interfere with participation.\n\nHistory of major gastrointestinal surgery that prevents adherence to the diet.\n\nPregnant or breastfeeding, or planning to become pregnant during the study period.\n\nAllergy or intolerance to key components of the KORMED diet (e.g., fish, nuts, legumes) that prevents safe participation.\n\nAny condition, in the investigator's judgment, that would make participation unsafe or limit the ability to complete the study.","ALL","19 Years","80 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.\n\nThe study seeks to answer the following primary question:\n\nIs the KORMED diet feasible and achievable for MGUS\u002FSMM patients, as measured by changes in K-MEDAS adherence scores over 12 weeks?\n\nSecondary questions include:\n\n1. 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?\n2. Is increased daily physical activity, measured by step counts, associated with favorable changes in metabolic and clinical parameters?\n3. Can combined dietary and activity-based lifestyle modification provide preliminary evidence supporting delayed disease progression in precursor plasma cell disorders?",[65,66],"Monoclonal Gammopathy of Undetermined Significance","Smoldering Myeloma","NOT_YET_RECRUITING","2026-01-20",{"date":70,"type":71},"2026-01-21","ACTUAL",{"date":73,"type":59},"2026-01-30",{"date":75,"type":59},"2027-07-15",{"name":5,"class":6},1]