Taiwan Green Propolis for Blood Lipids and Body Fat in Patients With MASLD (TGP-MASLD)
A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Effectiveness of Taiwan Green Propolis Supplementation on Blood Lipids and Body Fat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic liver condition linked to excess body fat, high blood lipids, and other metabolic problems. Taiwan green propolis is a natural health product collected by bees from plants, which has shown potential benefits for blood lipids and body fat in laboratory and animal studies. However, its effects in people with MASLD have not been well established in clinical trials.
This study is a double-blind, randomized, placebo-controlled trial enrolling up to 60 adults with MASLD at Dalin Tzu Chi Hospital in Taiwan. Eligible participants are randomly assigned in a 1:1 ratio to receive either Taiwan green propolis capsules or matching placebo capsules for 12 weeks. Participants take 2 capsules before breakfast and 2 capsules before dinner each day (4 capsules per day total). Neither participants nor the research team know which capsules are being taken until the study ends.
The study measures changes in blood lipids (triglycerides, total cholesterol, LDL-C, and HDL-C), body fat percentage, body weight, waist circumference, liver enzymes, blood sugar levels, inflammatory markers, and health-related quality of life. Liver fat and scarring are assessed by abdominal ultrasound before and after the intervention. Gut microbiota samples are also collected. Assessments are conducted at baseline, at 4 weeks, 8 weeks, 12 weeks (end of intervention), and at follow-up visits 2 weeks and 12 weeks after the intervention ends.
The goal of this study is to provide scientific evidence on whether Taiwan green propolis can safely and effectively improve blood lipids, body fat, and metabolic health in people with MASLD, and to explore the relationship between physiological improvements and health behavior changes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants are enrolled at Dalin Tzu Chi Hospital (Dalin Township, Chiayi County, Taiwan). Random allocation is performed using a computer-generated random number sequence with a 1:1 male-to-female ratio, further stratified by physiological life stage (reproductive age, middle age, perimenopausal/menopausal, and elderly). Allocation concealment is achieved using sequentially numbered opaque sealed envelopes, which are opened in order after informed consent is obtained.
Intervention arm: Taiwan green propolis capsules (propolis extract), 2 capsules before breakfast and 2 capsules before dinner (4 capsules/day) for 12 consecutive weeks. Capsules may be stored at room temperature.
Placebo arm: Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and administration schedule to the propolis capsules.
Both participants and all research personnel involved in assessment and data collection are blinded to group assignment throughout the study period.
Assessment schedule:
- Baseline: Anthropometrics (height, weight, BMI, waist/hip circumference), skinfold thickness at 7 sites, blood pressure, heart rate, full blood lipid panel, liver enzymes (AST/ALT/GGT), fasting glucose, HbA1c, complete blood count, biochemistry (albumin, BUN, creatinine, uric acid), thyroid function (TSH, T3, free T4), inflammatory cytokines (IL-6, IL-8, IL-1beta), body composition by bioelectrical impedance (InBody), abdominal ultrasound (hepatic steatosis and fibrosis grading), fecal specimen, and all questionnaires.
- Weeks 4 and 8: Anthropometrics, skinfold thickness, blood pressure, body composition, blood lipid panel, liver enzymes, fasting glucose, HbA1c, biochemistry, ESAS-R. Inflammatory cytokines added at Week 8.
- Week 12 (end of intervention): Full assessment as baseline, except thyroid function; all questionnaires repeated; dietary and activity diary (3 days).
- Week 14 (2 weeks post-intervention): Anthropometrics, blood lipid panel, ESAS-R.
- Week 24 (12 weeks post-intervention): Full assessment as baseline; all questionnaires; fecal specimen.
Questionnaires administered include: General questionnaire, Health Belief Model questionnaire, International Physical Activity Questionnaire (IPAQ Taiwan short form), EQ-5D-5L, Dietary Behavior Scale, and Edmonton Symptom Assessment System-Revised (ESAS-R).
Standard care including dietary counseling and appropriate physical activity is provided to all participants throughout the study, regardless of group assignment.
Primary statistical analyses will use intention-to-treat principles. Mixed-effects models for repeated measures (MMRM) or analysis of covariance (ANCOVA) will compare changes from baseline between groups for primary and secondary outcomes. Descriptive statistics will be reported for all variables.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tsai-Wei Huang, PhD
- Número de teléfono: +886227361661
- Correo electrónico: tsaiwei@tmu.edu.tw
Ubicaciones de estudio
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Dalin, Taiwán
- Reclutamiento
- Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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Contacto:
- KUO-CHIH TSENG, MD, PhD
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Contacto:
- Hsin-Yu Kuo, MS
- Número de teléfono: +886-5-2648000
- Correo electrónico: g462112027@tmu.edu.tw
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 80 years
Diagnosis of hepatic steatosis (fatty liver) confirmed by abdominal ultrasound, PLUS at least one of the following metabolic risk factors:
- Overweight or obesity: BMI >= 23 kg/m^2
- Elevated waist circumference: >= 90 cm in men or >= 80 cm in women (South Asian and Chinese criteria)
- Dysglycemia or type 2 diabetes: prediabetes (HbA1c 5.7-6.4%, or fasting glucose 100-125 mg/dL, or OGTT 2-hour glucose 140-199 mg/dL) OR type 2 diabetes (HbA1c >= 6.5%, or fasting glucose >= 126 mg/dL, or OGTT 2-hour glucose >= 200 mg/dL, or current pharmacological treatment for type 2 diabetes)
- Elevated triglycerides: >= 150 mg/dL or currently on lipid-lowering therapy
- Low HDL-C: <= 39 mg/dL in men or <= 50 mg/dL in women, or currently on lipid-lowering therapy
- Elevated blood pressure: >= 130/85 mmHg or currently on antihypertensive treatment
Exclusion Criteria:
- Known allergy to honey, propolis, multiple pollens, or alcohol
- Psychiatric disorder or cognitive impairment
- Currently pregnant or breastfeeding
- Significant endocrine abnormality, or major disease of the heart, liver (other than MASLD), or kidney
- Difficulty swallowing capsules
- Dementia, impaired consciousness, or inability to respond to questionnaires
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Taiwan Green Propolis
Participants receive Taiwan green propolis capsules, 2 capsules before breakfast and 2 capsules before dinner (4 capsules/day) for 12 consecutive weeks.
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Taiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.
Otros nombres:
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Comparador de placebos: Placebo
Participants receive placebo capsules identical in appearance to the active intervention, 2 capsules before breakfast and 2 capsules before dinner (4 capsules/day) for 12 consecutive weeks.
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Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Serum Lipid Profile
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in fasting serum triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), measured in mg/dL.
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Skeletal Muscle Mass (InBody)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in skeletal muscle mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Change in Fat Mass (InBody)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in total fat mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Change in Bone Mass (InBody)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in bone mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Waist and Hip Circumference
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in waist circumference (cm) and hip circumference (cm) measured by tape measure.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Change in Skinfold Thickness
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in skinfold thickness (mm) measured at 7 body sites: chest, axilla, triceps, subscapular, abdomen, suprailiac, and thigh.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Change in Liver Enzymes
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT), measured in U/L.
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Fasting Plasma Glucose
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in fasting plasma glucose concentration, measured in mg/dL.
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Inflammatory Cytokines
Periodo de tiempo: Baseline, Week 8, Week 12, and Week 24
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Change from baseline in serum interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1 beta (IL-1β) concentrations.
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Baseline, Week 8, Week 12, and Week 24
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Change in Hepatic Steatosis Grade
Periodo de tiempo: Baseline and Week 24
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Change from baseline in hepatic steatosis grade assessed by abdominal ultrasound (graded as none, mild, moderate, or severe).
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Baseline and Week 24
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Change in Body Weight
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in body weight, measured in kilograms (kg).
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Blood Pressure
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, and Week 24
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Change from baseline in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg), measured by sphygmomanometer.
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Baseline, Week 4, Week 8, Week 12, and Week 24
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Change in Blood Pressure and Heart Rate
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and resting heart rate (bpm).
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in EQ-5D-5L Index Score
Periodo de tiempo: Baseline, Week 12, and Week 24
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Change from baseline in EQ-5D-5L utility index score.
Scores range from -0.281 to 1.0; higher scores indicate better health-related quality of life.
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Baseline, Week 12, and Week 24
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Change in Physical Activity Level (IPAQ)
Periodo de tiempo: Baseline and Week 24
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Change from baseline in total physical activity measured by the International Physical Activity Questionnaire (IPAQ) Taiwan short form, reported as MET-minutes per week.
Higher scores indicate greater physical activity.
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Baseline and Week 24
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Change in Health Belief Model Questionnaire Score
Periodo de tiempo: Baseline and Week 24
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Change from baseline in Health Belief Model questionnaire scores across six subscales: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, behavioral intention, and self-efficacy.
Each item rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree).
Higher scores indicate stronger health beliefs.
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Baseline and Week 24
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Change in Dietary Behavior
Periodo de tiempo: Baseline and Week 24
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Change from baseline in dietary behavior questionnaire score assessing eating habits and food intake patterns.
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Baseline and Week 24
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Symptom Burden (ESAS-R)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Symptom burden assessed by the Edmonton Symptom Assessment System-Revised (ESAS-R).
Each symptom rated 0-10; higher scores indicate greater symptom severity.
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Gut Microbiota Composition
Periodo de tiempo: Baseline and Week 24
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Change from baseline in gut microbiota composition and diversity assessed from fecal specimens collected in sterile containers and stored at -20°C.
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Baseline and Week 24
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Incidence of Adverse Events
Periodo de tiempo: Throughout study, up to Week 24
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Incidence, type, and severity of adverse events and clinically significant abnormal laboratory findings throughout the study period.
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Throughout study, up to Week 24
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Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in BMI, calculated as weight in kilograms divided by height in meters squared (kg/m^2).
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Glycated Hemoglobin (HbA1c)
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in glycated hemoglobin (HbA1c), measured as a percentage (%).
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in Hepatic Fibrosis Severity
Periodo de tiempo: Baseline and Week 24
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Change from baseline in hepatic fibrosis severity assessed by abdominal ultrasound.
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Baseline and Week 24
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Change in Resting Heart Rate
Periodo de tiempo: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change from baseline in resting heart rate, measured in beats per minute (bpm).
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Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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Change in EQ Visual Analogue Scale (EQ-VAS) Score
Periodo de tiempo: Baseline, Week 12, and Week 24
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Change from baseline in EQ-VAS score.
Scores range from 0 to 100; higher scores indicate better self-rated health.
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Baseline, Week 12, and Week 24
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Trastornos del metabolismo de los lípidos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Hígado graso
- Dislipidemias
Otros números de identificación del estudio
- MASLD_Dalin
- A11303004 (Otro identificador: Dalin Tzu Chi Hospital Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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