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NCT07114926Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
1 Jul 2025
Start date
30 Aug 2025
Primary completion date
30 Sept 2028
Lead sponsor
Kuo,HSIN-YU
NCT number
NCT07114926

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 30 Aug 2025 to the primary completion date, 30 Sept 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Buddhist Tzu Chi Medical Foundation, Dalin Tzu Chi Hospital
Coordinator of this site? Confirm its status
Chiayi CityTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.