The effect of propolis dietary supplement consumption on indices of high-sensitivity C-reactive protein, testosterone hormone and metabolic profile in women with polycystic ovary syndrome (PCOS)

The effect of propolis diet supplement on the status of the body's inflammatory index, testosterone and metabolic profile in women with polycystic ovary syndrome

Randomized double-blind, control trial of phase 3 with parallel groups design of 56 patients. An authentic website is used for randomization.

We select 56 women with PCOS referring to the gynecologist clinic located in Shahid Beheshti Hospital in Isfahan and we will divide them into 2 groups receiving propolis supplement and placebo. For proper blindness, the drug and placebo will be exactly the same and none of the participants and researchers will be aware of them until the end of the study. At the beginning of the study and 12 weeks after the intervention, blood samples will be taken and the necessary measurements will done. During this period, participants are advised to eat a healthy diet and perform 30-45 minutes of physical activity daily.

inclusion criteria: Diagnosis of PCOS according to the Rotterdam criteria, Age between 18 and 45 years, Do not take any drug other than metformin Criteria for not entering: Hormone therapy or taking contraceptive pills, History of gestational hypertension, Pregnancy or breastfeeding, Tobacco and alcohol consumption, having certain diseases

Intervention group: 2 tablets of 350 mg daily containing 250 mg of propolis extract before lunch and dinner, for 12 weeks. Placebo group: 2 tablets of 350 mg placebo daily containing 350 mg microcrystalline cellulose before lunch and dinner for 12 weeks.

Fasting blood sugar; Insulin; HOMA-IR index; triglyceride; Cholesterol; High-density lipoprotein; Low-density lipoprotein; testosterone; High sensitivity C-reactive protein; Status of menstrual disorders; blood pressure; Height; Weight; Waist; Waist to hip ratio; BMI

Due to the coronavirus conditions in the country and the impossibility of starting the project on the predicted dates, it was necessary to change the start and end dates of the recruitment.

Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age. It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it.

For proper blinding, the drug and placebo will be exactly the same in color, size, and odor, and none of the participants and researchers will be aware of them until the end of the study, except for the pharmacist.

Data can be shared after people are not identified.

access 1 year after publishing results

Researchers working in academic and scientific institutions

The data will be available in order to know the details of the research and any secondary analysis of the data is allowed due to the permission of the project owner.

Dr. Gholamreza Askari, Department of Community Nutrition, School of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib St. Askari@mui.ac.ir

Submit your application via email to eabbasi97@yahoo.com if your application is approved, you will receive the documents within a maximum of 1 month.