Clinical trial NCT06903546: The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients
Official title: The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Keywords: Propolis
Diabetes Mellitus Type 2
Low Density Lipoprotein
High Density Lipoprotein
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 64
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated into two groups that will recieve either propolis or plasebo. The study model is double-blinded trial.

The participants are patients undergoing treatment for type 2 diabetes in multiple sub-dictrict health centre in Central Jakarta and will be screened based on inclusion and exclusion criteria.
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Low Density Lipoprotein
timeFrame: 8 weeks
measure: High Density Lipoprotein
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia Faculty of Biomedical Science
Study officials:
affiliation: Indonesia University
name: Dwirini R Gunarti, Biomed Science
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.