The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients

The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta

The goal of this clinical trial is to learn if propolis administration works to change the level of Low Density Lipoprotein (LDL) and High Density Lipoprotein cholesterol (HDL) in diabetic type 2 patients.

The main questions it aims to answer are:

- Is giving 1 drops/ 10kg/ times, twice daily for 8 weeks will change the level of LDL and HDL level in diabetic type 2 patients compared to placebo? Researchers will compare propolis to a placebo (a look-alike substance that contains no drug) to see if propolis works to change LDL and HDL cholesterol level.

Participants will:

• Take propolis or a placebo, 2 times daily with given dose (1 drops/10 kg/times) every day for 2 months
• Visit the sub-district health centre once every 2 weeks for checkups
• Get their blood checked before and after intervention

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Propolis drops; Other: Placebo

Detailed Description

Subject allocation into groups will be made by third party to ensure masking/ blinding protocol.

Data that will be taken from participants :

• Private information
• Medication history (for type 2 Diabetes Mellitus)
• Food intake (calories, fats, carbohydrate, protein, and flavonoid intake)
• Physical activity status

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dwirini R Gunarti, Biomed Science; Phone Number: +62 8118382301; Email: rinairet@gmail.com
• Study Contact Backup: Name: Wiryani Sentosa, MD; Phone Number: +62 81210977847; Email: wiryani@ymail.com

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Recruiting
    • University of Indonesia Faculty of Biomedical Science
    • Contact: Dwirini R Gunarti; Phone Number: +62 8118382301; Email: rinairet@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Controlled Diabetes Mellitus type 2 with HbA1c <7.5%
• BMI 23-35 kg/m2
• On anti-cholesterol therapy

Exclusion Criteria:

• Using injection therapy (insulin or GLP-1 RA)
• History of bees product allergy
• Active smoker
• Consuming alcohol
• Altered liver (ALT>35 IU/L) and kidney (eGFR<90 mL/min) function
• Pregnant and breastfeeding women
• History of cardiovascular disease (heart attack, stroke)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This group will receive the intervention, which in this study is propolis with dose given 1 drop/kg/time given, 2 times daily, for 8 weeks (2 months)	Drug: Propolis drops; The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority
Placebo Comparator: Control group; This group will receive placebo (a look-alike substance that contains no drug) with dose given 1 drop/kg/time given, 2 times daily, for 8 weeks (2 months)	Other: Placebo; The given placebo are look-alike substance with no effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Density Lipoprotein	LDL level will be measured twice, before and after intervention	8 weeks
High Density Lipoprotein	HDL will be measured twice, before and after intervention	8 weeks

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dwirini R Gunarti, Biomed Science, Indonesia University

Publications and helpful links

General Publications

• Zakerkish M, Jenabi M, Zaeemzadeh N, Hemmati AA, Neisi N. The Effect of Iranian Propolis on Glucose Metabolism, Lipid Profile, Insulin Resistance, Renal Function and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial. Sci Rep. 2019 May 13;9(1):7289. doi: 10.1038/s41598-019-43838-8.
• Samadi N, Mozaffari-Khosravi H, Rahmanian M, Askarishahi M. Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: a randomized, double-blind clinical trial. J Integr Med. 2017 Mar;15(2):124-134. doi: 10.1016/S2095-4964(17)60315-7.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Mellitus Type 2; Propolis; High Density Lipoprotein; Low Density Lipoprotein
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Anti-Infective Agents; Propolis
• Other Study ID Numbers: 24-10-1677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidentiality issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No