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Taiwan Green Propolis for Blood Lipids and Body Fat in Patients With MASLD (TGP-MASLD)

2 июля 2026 г. обновлено: Tsai-Wei Huang, Taipei Medical University

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Tsai-Wei Huang, PhD
  • Номер телефона: +886227361661
  • Электронная почта: tsaiwei@tmu.edu.tw

Места учебы

  • Тайвань
      • Dalin, Тайвань
        • Рекрутинг
        • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Контакт:
          • KUO-CHIH TSENG, MD, PhD
        • Контакт:
          • Hsin-Yu Kuo, MS
          • Номер телефона: +886-5-2648000
          • Электронная почта: g462112027@tmu.edu.tw

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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:

    1. Overweight or obesity: BMI >= 23 kg/m^2
    2. Elevated waist circumference: >= 90 cm in men or >= 80 cm in women (South Asian and Chinese criteria)
    3. 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)
    4. Elevated triglycerides: >= 150 mg/dL or currently on lipid-lowering therapy
    5. Low HDL-C: <= 39 mg/dL in men or <= 50 mg/dL in women, or currently on lipid-lowering therapy
    6. 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Диетическая добавка: Taiwan green propolis capsule
Taiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.
Другие имена:
  • Green propolis
Плацебо Компаратор: 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.
Диетическая добавка: Placebo capsule
Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.
Другие имена:
  • Плацебо

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Serum Lipid Profile
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
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.
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Skeletal Muscle Mass (InBody)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in skeletal muscle mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Baseline, Week 4, Week 8, Week 12, and Week 24
Change in Fat Mass (InBody)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in total fat mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Baseline, Week 4, Week 8, Week 12, and Week 24
Change in Bone Mass (InBody)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in bone mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Baseline, Week 4, Week 8, Week 12, and Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Waist and Hip Circumference
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in waist circumference (cm) and hip circumference (cm) measured by tape measure.
Baseline, Week 4, Week 8, Week 12, and Week 24
Change in Skinfold Thickness
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in skinfold thickness (mm) measured at 7 body sites: chest, axilla, triceps, subscapular, abdomen, suprailiac, and thigh.
Baseline, Week 4, Week 8, Week 12, and Week 24
Change in Liver Enzymes
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT), measured in U/L.
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Fasting Plasma Glucose
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in fasting plasma glucose concentration, measured in mg/dL.
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Inflammatory Cytokines
Временное ограничение: Baseline, Week 8, Week 12, and Week 24
Change from baseline in serum interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1 beta (IL-1β) concentrations.
Baseline, Week 8, Week 12, and Week 24
Change in Hepatic Steatosis Grade
Временное ограничение: Baseline and Week 24
Change from baseline in hepatic steatosis grade assessed by abdominal ultrasound (graded as none, mild, moderate, or severe).
Baseline and Week 24
Change in Body Weight
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in body weight, measured in kilograms (kg).
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Blood Pressure
Временное ограничение: Baseline, Week 4, Week 8, Week 12, and Week 24
Change from baseline in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg), measured by sphygmomanometer.
Baseline, Week 4, Week 8, Week 12, and Week 24
Change in Blood Pressure and Heart Rate
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and resting heart rate (bpm).
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in EQ-5D-5L Index Score
Временное ограничение: Baseline, Week 12, and Week 24
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.
Baseline, Week 12, and Week 24
Change in Physical Activity Level (IPAQ)
Временное ограничение: Baseline and Week 24
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.
Baseline and Week 24
Change in Health Belief Model Questionnaire Score
Временное ограничение: Baseline and Week 24
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.
Baseline and Week 24
Change in Dietary Behavior
Временное ограничение: Baseline and Week 24
Change from baseline in dietary behavior questionnaire score assessing eating habits and food intake patterns.
Baseline and Week 24
Symptom Burden (ESAS-R)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Symptom burden assessed by the Edmonton Symptom Assessment System-Revised (ESAS-R). Each symptom rated 0-10; higher scores indicate greater symptom severity.
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Gut Microbiota Composition
Временное ограничение: Baseline and Week 24
Change from baseline in gut microbiota composition and diversity assessed from fecal specimens collected in sterile containers and stored at -20°C.
Baseline and Week 24
Incidence of Adverse Events
Временное ограничение: Throughout study, up to Week 24
Incidence, type, and severity of adverse events and clinically significant abnormal laboratory findings throughout the study period.
Throughout study, up to Week 24
Change in Body Mass Index (BMI)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in BMI, calculated as weight in kilograms divided by height in meters squared (kg/m^2).
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Glycated Hemoglobin (HbA1c)
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in glycated hemoglobin (HbA1c), measured as a percentage (%).
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in Hepatic Fibrosis Severity
Временное ограничение: Baseline and Week 24
Change from baseline in hepatic fibrosis severity assessed by abdominal ultrasound.
Baseline and Week 24
Change in Resting Heart Rate
Временное ограничение: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change from baseline in resting heart rate, measured in beats per minute (bpm).
Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24
Change in EQ Visual Analogue Scale (EQ-VAS) Score
Временное ограничение: Baseline, Week 12, and Week 24
Change from baseline in EQ-VAS score. Scores range from 0 to 100; higher scores indicate better self-rated health.
Baseline, Week 12, and Week 24

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Taipei Medical University

Соавторы

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 мая 2025 г.

Первичное завершение (Оцененный)

30 сентября 2028 г.

Завершение исследования (Оцененный)

30 сентября 2028 г.

Даты регистрации исследования

Первый отправленный

27 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

2 июля 2026 г.

Первый опубликованный (Действительный)

9 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • MASLD_Dalin
  • A11303004 (Другой идентификатор: Dalin Tzu Chi Hospital Research Ethics Committee)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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