Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD
NCT ID: NCT07114926
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-30
2028-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Group
Take two capsules of Taiwan Green Propolis (each containing 500 mg/mL of propolis) before breakfast and dinner daily, totaling four capsules/day for 12 consecutive weeks.
Taiwanese green propolis
Intervention Details:
Experimental Group: Take two capsules of Taiwan Green Propolis (each containing 500 mg/mL of propolis) before breakfast and dinner daily, totaling four capsules/day for 12 consecutive weeks.
During the intervention period, both groups will maintain their usual diet and activity levels and receive the same health education on nutrition and exercise.
Control group
Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.
placebo
Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.
Interventions
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Taiwanese green propolis
Intervention Details:
Experimental Group: Take two capsules of Taiwan Green Propolis (each containing 500 mg/mL of propolis) before breakfast and dinner daily, totaling four capsules/day for 12 consecutive weeks.
During the intervention period, both groups will maintain their usual diet and activity levels and receive the same health education on nutrition and exercise.
placebo
Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Kuo,HSIN-YU
OTHER
Responsible Party
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Kuo,HSIN-YU
Principal Investigator
Locations
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Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital
Chiayi City, Dalin, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A11303004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N202305017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A11303004
Identifier Type: -
Identifier Source: org_study_id
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