Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07692438

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease NAFLD, Dyslipidemia, Obesity & Overweight

Full registry criteria

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

Treatments and study arms

Taiwan green propolis capsule

Dietary Supplement

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

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.

Primary outcomes

Change in Serum Lipid ProfileBaseline, 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.

Change in Skeletal Muscle Mass (InBody)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.

Change in Fat Mass (InBody)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.

Change in Bone Mass (InBody)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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation🇹🇼 Dalin, Taiwan

Open map

Hsin-Yu Kuo, MSContact

Email · Call +886-5-2648000

KUO-CHIH TSENG, MD, PhDContact