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

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.

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:

• 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

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