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NCT Number: NCT07114926

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

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.

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Key information

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital

Chiayi City, Dalin, 662, Taiwan

Location contact

HSIN-YU kuo

CONTACT

[email protected]

866+932656089

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Taiwanese green propolis

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.

Other names: placebo

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    diet

  2. 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

    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

  3. gut microbiota

    Time frame: Collected at baseline and Week 12 to assess gut microbiota changes

    Stool Samples After collecting fecal samples, they are sent to Microbacteria Ark Company for testing of microbes at low temperature.

  4. 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

    (IL-6, IL-8, IL-1β)

  5. 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

    Health Belief Questionnaire

  6. 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

    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

  7. 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)

    physical activity

Study contacts

Contact information is provided by the study sponsor or research team.

HSIN-YU KUO

CONTACT

[email protected]

+8862648000 ext. 5916

Sponsors and collaborators

Lead sponsor

Kuo,HSIN-YU

Other

Registry information

Acronym: TGP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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