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Metabolic Dysfunction-Associated Steatotic Liver DiseaseTGP-MASLDNCT07692438

Taiwan Green Propolis for Blood Lipids and Body Fat in Patients With MASLD

A study testing Taiwan green propolis capsule in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-alcoholic Fatty Liver Disease NAFLD, run by Taipei Medical University at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Taiwan green propolis capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTaiwan
Study dates
28 May 2025to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tsai-Wei Huang, PhD contact

+886227361661

tsaiwei@tmu.edu.tw

Taiwan1 site, 1 recruiting

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Dalin

    Hsin-Yu Kuo, MS, +886-5-2648000, g462112027@tmu.edu.tw

    KUO-CHIH TSENG, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Taiwan green propolis capsule, Placebo capsule
Keywords
green propolis, propolis, dietary supplement, MASLD, fatty liver, blood lipids, randomized controlled trial
Medical subject headings
Dyslipidemias, Obesity, Overweight, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taiwan green propolis capsuleDietary supplement

    Also called Green propolis

    Taiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.

  • Placebo capsuleDietary supplement

    Also called Placebo

    Capsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.

Study groups in NCT07692438
Study groupRoleWhat they receive
Taiwan Green PropolisExperimentalParticipants receive Taiwan green propolis capsules, 2 capsules before breakfast and 2 capsules before dinner (4 capsules/day) for 12 consecutive weeks.
Receives: Dietary Supplement: Taiwan green propolis capsule
PlaceboPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Serum Lipid Profile

    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.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  2. Change in Skeletal Muscle Mass (InBody)

    Change from baseline in skeletal muscle mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  3. Change in Fat Mass (InBody)

    Change from baseline in total fat mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  4. Change in Bone Mass (InBody)

    Change from baseline in bone mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

Secondary outcomes (21)

  1. Change in Waist and Hip Circumference

    Change from baseline in waist circumference (cm) and hip circumference (cm) measured by tape measure.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  2. Change in Skinfold Thickness

    Change from baseline in skinfold thickness (mm) measured at 7 body sites: chest, axilla, triceps, subscapular, abdomen, suprailiac, and thigh.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  3. Change in Liver Enzymes

    Change from baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT), measured in U/L.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  4. Change in Fasting Plasma Glucose

    Change from baseline in fasting plasma glucose concentration, measured in mg/dL.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  5. Change in Inflammatory Cytokines

    Change from baseline in serum interleukin-6 (IL-6), interleukin-8 (IL-8), and interleukin-1 beta (IL-1β) concentrations.

    Measured: Baseline, Week 8, Week 12, and Week 24

  6. Change in Hepatic Steatosis Grade

    Change from baseline in hepatic steatosis grade assessed by abdominal ultrasound (graded as none, mild, moderate, or severe).

    Measured: Baseline and Week 24

  7. Change in Body Weight

    Change from baseline in body weight, measured in kilograms (kg).

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  8. Change in Blood Pressure

    Change from baseline in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg), measured by sphygmomanometer.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  9. Change in Blood Pressure and Heart Rate

    Change from baseline in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and resting heart rate (bpm).

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  10. Change in EQ-5D-5L Index Score

    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.

    Measured: Baseline, Week 12, and Week 24

  11. Change in Physical Activity Level (IPAQ)

    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.

    Measured: Baseline and Week 24

  12. Change in Health Belief Model Questionnaire Score

    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.

    Measured: Baseline and Week 24

  13. Change in Dietary Behavior

    Change from baseline in dietary behavior questionnaire score assessing eating habits and food intake patterns.

    Measured: Baseline and Week 24

  14. Symptom Burden (ESAS-R)

    Symptom burden assessed by the Edmonton Symptom Assessment System-Revised (ESAS-R). Each symptom rated 0-10; higher scores indicate greater symptom severity.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  15. Change in Gut Microbiota Composition

    Change from baseline in gut microbiota composition and diversity assessed from fecal specimens collected in sterile containers and stored at -20°C.

    Measured: Baseline and Week 24

  16. Incidence of Adverse Events

    Incidence, type, and severity of adverse events and clinically significant abnormal laboratory findings throughout the study period.

    Measured: Throughout study, up to Week 24

  17. Change in Body Mass Index (BMI)

    Change from baseline in BMI, calculated as weight in kilograms divided by height in meters squared (kg/m^2).

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  18. Change in Glycated Hemoglobin (HbA1c)

    Change from baseline in glycated hemoglobin (HbA1c), measured as a percentage (%).

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  19. Change in Hepatic Fibrosis Severity

    Change from baseline in hepatic fibrosis severity assessed by abdominal ultrasound.

    Measured: Baseline and Week 24

  20. Change in Resting Heart Rate

    Change from baseline in resting heart rate, measured in beats per minute (bpm).

    Measured: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24

  21. Change in EQ Visual Analogue Scale (EQ-VAS) Score

    Change from baseline in EQ-VAS score. Scores range from 0 to 100; higher scores indicate better self-rated health.

    Measured: Baseline, Week 12, and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start28 May 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two parallel arms (Taiwan green propolis or placebo) in a 1:1 ratio and receive the assigned intervention for 12 consecutive weeks.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692438
Sponsor's protocol ID
MASLD_Dalin
Other IDs
A11303004
Acronym
TGP-MASLD
Status last verified
Jul 2026
First submitted
27 Jun 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.

    PubMed 37364790

Questions about this trial

What is this clinical trial studying?

A study testing Taiwan green propolis capsule in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-alcoholic Fatty Liver Disease NAFLD, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tsai-Wei Huang, PhD (+886227361661, tsaiwei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Lipid Profile (time frame: Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692438, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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