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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum Lipid Profile
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Serum Lipid Profile
时间窗: 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.
Change in Skeletal Muscle Mass (InBody)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Change in Hepatic Steatosis Grade(Baseline and Week 24)
- Change in Body Weight(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in Blood Pressure(Baseline, Week 4, Week 8, Week 12, and Week 24)
- Change in Blood Pressure and Heart Rate(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in EQ-5D-5L Index Score(Baseline, Week 12, and Week 24)
- Change in Physical Activity Level (IPAQ)(Baseline and Week 24)
- Change in Health Belief Model Questionnaire Score(Baseline and Week 24)
- Change in Dietary Behavior(Baseline and Week 24)
- Symptom Burden (ESAS-R)(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in Gut Microbiota Composition(Baseline and Week 24)
- Incidence of Adverse Events(Throughout study, up to Week 24)
- Change in Body Mass Index (BMI)(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in Glycated Hemoglobin (HbA1c)(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in Hepatic Fibrosis Severity(Baseline and Week 24)
- Change in Resting Heart Rate(Baseline, Week 4, Week 8, Week 12, Week 14, and Week 24)
- Change in EQ Visual Analogue Scale (EQ-VAS) Score(Baseline, Week 12, and Week 24)
研究者
Tsai-Wei Huang
Professor, College of Nursing, Taipei Medical University
Taipei Medical University