MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseTGPNCT07114926
Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD
A study testing Taiwanese green propolis in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Kuo,HSIN-YU at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Taiwanese green propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Male > 90 cm
- Female > 80 cm
- Not currently receiving any lipid-lowering medication treatment. MASLD
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital
Chiayi City, Dalin, 662
HSIN-YU kuo, 866+932656089, g462112027@tmu.edu.tw
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Taiwanese green propolis, placebo
- Keywords
- Taiwanese green propolis, MASLD-Metabolic Dysfunction-Associated Steatotic Liver Disease, blood lipids, body fat, Health Belief Model, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiwanese green propolisDietary supplement
Also called placebo
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.
placeboDietary supplement
Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Dietary Supplement: Taiwanese green propolis |
| Control group | Placebo comparator | Take placebo capsules identical in appearance, smell, and content, with the same dosage and frequency. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
In body
body fat composition
Measured: 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
Changes in blood lipids
TG, TC, HDL, LDL
Measured: 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
fatty liver status
assessed via abdominal ultrasound
Measured: 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
Secondary outcomes (7)
Eating Behavior Scale
diet
Measured: 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
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
Measured: 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
Stool Samples After collecting fecal samples, they are sent to Microbacteria Ark Company for testing of microbes at low temperature.
Measured: Collected at baseline and Week 12 to assess gut microbiota changes
inflammatory markers
(IL-6, IL-8, IL-1β)
Measured: 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
Health Belief Questionnaire
Measured: 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
ESAS Fatigue Scale
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
Measured: 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
IPAQ
physical activity
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design adopted a parallel, double-blind, randomized approach to the experimental group (propolis) and the control group (placebo).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuo,HSIN-YU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kuo,HSIN-YU, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114926
- Sponsor's protocol ID
- A11303004
- Other IDs
- A11303004, N202305017
- Acronym
- TGP
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collect all to IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Function of Taiwan Green Propolis in Reducing Blood Lipids and Body Fat in Sub-healthy Groups: MASLD
- ClinicalTrials.gov ID
- NCT07114926
- Acronym / sponsor ID
- TGP / A11303004
- Keywords
- Taiwanese green propolis, MASLD-Metabolic Dysfunction-Associated Steatotic Liver Disease, blood lipids, body fat, Health Belief Model, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kuo,HSIN-YUUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study design adopted a parallel, double-blind, randomized approach to the experimental group (propolis) and the control group (placebo).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Taiwanese green propolisTake 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. |
| Control group | Placebo comparator | Dietary Supplement: placeboTake placebo capsules identical in appearance, smell, and content, with the same dosage and frequency. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 80 years.
- Total cholesterol (TC) > 200 mg/dL
- Triglycerides (TG) > 200 mg/dL
- LDL cholesterol > 130 mg/dL
- Male > 90 cm
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taiwanese green propolisAlso: placeboIntervention 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. | Dietary supplement | Experimental Group |
| placeboTake placebo capsules identical in appearance, smell, and content, with the same dosage and frequency. | Dietary supplement | Control group |
Primary outcome
In body
Time frame: 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
Time frame: 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 frame: 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
7 secondary outcomes
Eating Behavior Scale
Time frame: 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 frame: 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
Time frame: Collected at baseline and Week 12 to assess gut microbiota changes
inflammatory markers
Time frame: 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 frame: 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
ESAS Fatigue Scale
Time frame: 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
IPAQ
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. Collect all to IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taiwanese green propolis in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Kuo,HSIN-YU at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HSIN-YU KUO (+8862648000 ext. 5916, g462112027@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In body (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.