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

2. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Taiwan
      • Dalin, Taiwan
        • Rekrutierung
        • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
        • Kontakt:
          • KUO-CHIH TSENG, MD, PhD
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: Taiwan green propolis capsule
Taiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.
Andere Namen:
  • Green propolis
Placebo-Komparator: 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.
Nahrungsergänzungsmittel: Placebo capsule
Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.
Andere Namen:
  • Placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Serum Lipid Profile
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Waist and Hip Circumference
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline and Week 24
Change from baseline in hepatic fibrosis severity assessed by abdominal ultrasound.
Baseline and Week 24
Change in Resting Heart Rate
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Taipei Medical University

Mitarbeiter

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Mai 2025

Primärer Abschluss (Geschätzt)

30. September 2028

Studienabschluss (Geschätzt)

30. September 2028

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MASLD_Dalin
  • A11303004 (Andere Kennung: Dalin Tzu Chi Hospital Research Ethics Committee)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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