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.
Adults aged 18 to 80 years
Overweight or obesity: BMI >= 23 kg/m²
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)
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
Parallel
Taiwan green propolis capsule
Dietary supplementTaiwan green propolis extract capsule taken orally, 4 capsules per day for 12 weeks.
Placebo capsule
Dietary supplementCapsules containing edible dextrin with vitamin B2 (approximately 0.1 mg/capsule), identical in appearance and regimen to the active intervention capsules.
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.
Change in Skeletal Muscle Mass (InBody)
Change from baseline in skeletal muscle mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Change in Fat Mass (InBody)
Change from baseline in total fat mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Change in Bone Mass (InBody)
Change from baseline in bone mass measured in kilograms (kg) by InBody bioelectrical impedance analysis.
Change in Waist and Hip Circumference
Change from baseline in waist circumference (cm) and hip circumference (cm) measured by tape measure.
Change in Skinfold Thickness
Change from baseline in skinfold thickness (mm) measured at 7 body sites: chest, axilla, triceps, subscapular, abdomen, suprailiac, and thigh.
Change in Liver Enzymes
Change from baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT), measured in U/L.
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose concentration, measured in mg/dL.
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Taipei Medical University
Lead sponsor
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborator
