Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD

Not Applicable

Not yet recruiting

• Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

• Registration Number: NCT07114926
• Lead Sponsor: Kuo,HSIN-YU

Brief Summary

This study investigates the effectiveness of Taiwanese green propolis in reducing blood lipids and body fat in sub-healthy individuals. The study design follows a parallel, double-blind, randomized assignment approach, dividing participants into an experimental group (propolis) and a control group (placebo). Researchers explained the study plan to participants, and after obtaining signed informed consent, participants were randomly assigned using a web-based program that generated random serial numbers. The randomization was stratified by gender (male-to-female ratio of 1:1) and physiological age groups (maturity, middle age, menopause, post-menopause, and old age). Serial numbers and group assignments were sequentially encoded and placed in opaque, consecutively numbered envelopes. After obtaining consent, researchers opened the sealed envelopes in order and assigned participants to either the experimental group (propolis) or the control group (placebo), with 30 participants in each group.

The experimental group received Taiwanese green propolis (which can be stored at room temperature) in capsule form, containing 500 mg/ml of propolis extract per capsule. Participants took two capsules before breakfast and two before dinner, totaling four capsules per day for 12 weeks. The control group received a placebo with the same dosage and administration method. All participants were instructed not to deliberately change their daily diet or exercise routines during the study. To assess adherence, participants recorded their daily propolis capsule intake. Additionally, the Health Belief Model questionnaire and the EQ-5D-5L quality of life questionnaire were used to evaluate whether the intervention with propolis, along with dietary and exercise education, contributed to increased awareness of health behaviors and improvements in quality of life.

The primary outcomes of the study include changes in blood lipids, body fat, blood glucose levels, liver fat, and liver fibrosis. The secondary outcomes focus on the correlation between health behavior awareness and quality of life.

Keywords: Taiwanese green propolis, sub-health, blood lipids, body fat, Health Belief Model, quality of life.

Detailed Description

Inclusion and Exclusion Criteria

Inclusion Criteria:

Aged 18 to 80 years.

Meet any of the following dyslipidemia indicators:

Total cholesterol (TC) \> 200 mg/dL

Triglycerides (TG) \> 200 mg/dL

LDL cholesterol \> 130 mg/dL

Overweight or obese (BMI ≥ 27) with abnormal waist circumference:

Male \> 90 cm

Female \> 80 cm

Not currently receiving any lipid-lowering medication treatment.

Exclusion Criteria:

Allergic to honey, propolis, various pollens, or alcohol.

Individuals with psychiatric disorders or cognitive impairments.

Pregnant or breastfeeding women.

Individuals with significant endocrine disorders or major diseases of the heart, liver, kidneys, or other organs.

Individuals with swallowing difficulties.

Individuals with dementia, impaired consciousness, or other cognitive disorders preventing informed consent.

Individuals already receiving formal lipid-lowering drug therapy.

Individuals with comorbid diabetes, chronic kidney disease, or isolated LDL \> 190 mg/dL.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-30
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Aged 18 to 80 years.

Meet any of the following dyslipidemia indicators:

Total cholesterol (TC) > 200 mg/dL

Triglycerides (TG) > 200 mg/dL

LDL cholesterol > 130 mg/dL

Overweight or obese (BMI ≥ 27) with abnormal waist circumference:

Male > 90 cm

Female > 80 cm

Not currently receiving any lipid-lowering medication treatment. MASLD

Exclusion Criteria

• Allergic to honey, propolis, various pollens, or alcohol.

Individuals with psychiatric disorders or cognitive impairments.

Pregnant or breastfeeding women.

Individuals with significant endocrine disorders or major diseases of the heart, liver, kidneys, or other organs.

Individuals with swallowing difficulties.

Individuals with dementia, impaired consciousness, or other cognitive disorders preventing informed consent.

Individuals already receiving formal lipid-lowering drug therapy.

Individuals with comorbid diabetes, chronic kidney disease, or isolated LDL > 190 mg/dL.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In body	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	body fat composition
Changes in blood lipids	Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	TG, TC, HDL, LDL
fatty liver status	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	assessed via abdominal ultrasound

Secondary Outcome Measures

Name	Time	Method
Eating Behavior Scale	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	diet
health beliefs	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	Health Belief Questionnaire
quality of life Questionnaire Assessments	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	EQ-5D-5L Quality of Life Questionnaire The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
gut microbiota	Collected at baseline and Week 12 to assess gut microbiota changes	Stool Samples After collecting fecal samples, they are sent to Microbacteria Ark Company for testing of microbes at low temperature.
inflammatory markers	Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	(IL-6, IL-8, IL-1β)
IPAQ	Baseline (bWeek 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends efore intervention)	physical activity
ESAS Fatigue Scale	Time Points for Data Collection: Baseline (before intervention) Week 4, Week 8, and Week 12 of the intervention Follow-up at Week 2 and Week 12 after the intervention ends	fatigue symptoms Please circle the number that best describes how you feel NOW Pain、 Tiredness、Drowsiness、Nausea、Lack of Appetitie、 Shortness of Breath、 Depression、Anxiety、Wellbeing 0 to 10 points, the lower the better

Trial Locations

Locations (1)

Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital; 🇨🇳 Chiayi City, Dalin, Taiwan