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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2028-09-30

Brief Summary

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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

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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.

Conditions

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MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study design adopted a parallel, double-blind, randomized approach to the experimental group (propolis) and the control group (placebo).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Group Type EXPERIMENTAL

Taiwanese green propolis

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

placebo

Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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placebo

Eligibility Criteria

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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. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuo,HSIN-YU

OTHER

Sponsor Role lead

Responsible Party

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Kuo,HSIN-YU

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital

Chiayi City, Dalin, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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HSIN-YU KUO

Role: CONTACT

+8862648000 ext. 5916

Facility Contacts

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HSIN-YU kuo

Role: primary

866+932656089

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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