Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- In body
研究概览
简要总结
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.
详细描述
Inclusion and Exclusion Criteria
Inclusion Criteria:
Aged 18 to 80 years.
Meet any of the following dyslipidemia indicators:
Total cholesterol (TC) > 200 mg/dL
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
- Double (Participant, Care Provider)
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
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
In body
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)
- 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)
- gut microbiota(Collected at baseline and Week 12 to assess gut microbiota changes)
- 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)
- 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))
- 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)
研究者
Kuo,HSIN-YU
Principal Investigator
Taipei Medical University