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

NCT07114926 | Not Yet Recruiting DMC

• 2 other identifiers: A11303004N202305017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Taiwanese green propolis; MASLD-Metabolic Dysfunction-Associated Steatotic Liver Disease; blood lipids; body fat; Health Belief Model; quality of life

Outcome Measures

Primary Outcomes (3)

• In body

  body fat composition

  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

  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

  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

  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 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

  Collected at baseline and Week 12 to assess gut microbiota changes

• inflammatory markers

  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 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

Study Arms (2)

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.

Dietary Supplement: Taiwanese green propolis

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

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.

Also known as: placebo

Experimental Group

placebo DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuo,HSIN-YU: lead

Study Sites (1)

Buddhist Tzu Chi Medical Foundation Dalin Tzu Chi Hospital

Chiayi City, Dalin, 662, Taiwan

Location

Central Study Contacts

HSIN-YU KUO

CONTACT

+8862648000; g462112027@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design adopted a parallel, double-blind, randomized approach to the experimental group (propolis) and the control group (placebo).

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 11, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 years after publication
• Access Criteria: 2 years after publication

Locations

TW (1)