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Набор скоро начнётся NCT07305662

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

Без фазы С лечением Monoclonal Gammopathy of Undetermined Significance Smoldering Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: KORMED Diet and Physical Activity Monitoring.
Кому может быть актуально
Состояния в реестре: Monoclonal Gammopathy of Undetermined Significance, Smoldering Myeloma. Базовые параметры: 19 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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?

Вмешательства

  • Поведенческое KORMED 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. Phys

Первичные конечные точки

  • Change in K-MEDAS Score From Baseline to 12 Weeks [Срок оценки: Baseline, 12 weeks]
Вторичные конечные точки (3)
  • Change in Body Mass Index (BMI) From Baseline to 52 Weeks [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks]
  • Change in Monoclonal Protein (M-protein) Levels From Baseline to 52 Weeks [Срок оценки: 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 [Срок оценки: Baseline, 12 weeks, 24 weeks, 52 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

South Korea · 1 центр
  • Seoul National University Bundang Hospital — Seongnam-si

Идентификаторы

NCT: NCT07305662 · B-2512-1017-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗