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

2026年7月2日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Tsai-Wei Huang, PhD
  • 電話番号：+886227361661
  • メール：tsaiwei@tmu.edu.tw

研究場所

  • 台湾
      • Dalin、台湾
        • 募集
        • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • コンタクト：
          • KUO-CHIH TSENG, MD, PhD
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：Taiwan green propolis capsule
Taiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.
他の名前：
  • Green propolis
プラセボコンパレーター：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.
ダイエットサプリメント：Placebo capsule
Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.
他の名前：
  • プラセボ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Serum Lipid Profile
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Waist and Hip Circumference
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Baseline and Week 24
Change from baseline in hepatic fibrosis severity assessed by abdominal ultrasound.
Baseline and Week 24
Change in Resting Heart Rate
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Taipei Medical University

協力者

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月28日

一次修了 (推定)

2028年9月30日

研究の完了 (推定)

2028年9月30日

試験登録日

最初に提出

2026年6月27日

QC基準を満たした最初の提出物

2026年7月2日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月9日

QC基準を満たした最後の更新が送信されました

2026年7月2日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MASLD_Dalin
  • A11303004 (その他の識別子：Dalin Tzu Chi Hospital Research Ethics Committee)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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