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

NCT07692438 | Recruiting

• 2 other identifiers: MASLD_DalinA11303004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Non-alcoholic Fatty Liver Disease NAFLD; Dyslipidemia; Obesity & Overweight; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

green propolis; propolis; dietary supplement; MASLD; fatty liver; blood lipids; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• 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.

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

• Change in Skeletal Muscle Mass (InBody)

  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)

  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)

  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

Secondary Outcomes (21)

• Change in Waist and Hip Circumference

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

• Change in Skinfold Thickness

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

• Change in Liver Enzymes

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

• Change in Fasting Plasma Glucose

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

• Change in Inflammatory Cytokines

  Baseline, Week 8, Week 12, and Week 24

Study Arms (2)

Taiwan Green Propolis

EXPERIMENTAL

Participants receive Taiwan green propolis capsules, 2 capsules before breakfast and 2 capsules before dinner (4 capsules/day) for 12 consecutive weeks.

Dietary Supplement: Taiwan green propolis capsule

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo capsule

Interventions

Taiwan green propolis capsule DIETARY_SUPPLEMENT

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

Also known as: Green propolis

Taiwan Green Propolis

Placebo capsule DIETARY_SUPPLEMENT

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: collaborator

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Dalin, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37364790 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Obesity; Overweight; Fatty Liver

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Central Study Contacts

Tsai-Wei Huang, PhD

CONTACT

+886227361661; tsaiwei@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and investigators are blinded to group assignment throughout the intervention period. Allocation concealment is maintained using sequentially numbered opaque sealed envelopes opened only after informed consent is obtained. The placebo capsules are identical in appearance, packaging, and administration schedule to the active intervention capsules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Nursing, Taipei Medical University

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 9, 2026
• Study Start: May 28, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)