The effect of propolis and placebo supplementation with weight loss diet on metabolic status, meta-inflammation, nutritional status and liver function in patients with non-alcoholic fatty liver

Determining the effect of propolis supplementation with weight loss diet on metabolic status, meta-inflammation, nutritional status and liver function in patients with non-alcoholic fatty liver: a randomized controlled clinical trial

Clinical trial with control group, double-blind, randomized, phase 3 on 46 patients. Pass15 software was used for randomization.

Individuals randomly assigned to the supplement and placebo groups will take propolis or placebo supplements for 8 weeks. At the beginning of the study, both groups will be given a weight loss diet individually.

Inclusion criteria included patients with non-alcoholic fatty liver (grade 1 and 2) of both sexes, age 20-50 years, BMI between 30-40 kg/m2, willingness to participate in the study and exclusion criteria included Pregnancy, lactation and menopause in women, allergies to propolis or honey products, smoking and alcohol use, use of medications, supplements or diets that affect liver enzyme levels and body weight in the last three months and having symptoms of recent infectious or inflammatory disease or surgery.

supplement group(three capsules containing 500 mg of propolis daily) placebo group(three capsules containing 500 mg of Corn starch) will receive for 8 weeks after each meal with weight loss diet.The amount of calories per person is calculated based on the Mifflin formula and 500 kcal will be deducted from the total calories.

FBS, Insulin, HOMA-IR, TC, TG, HDL-C, MCP-1, TNF-α, TLR-4, weight, height, BMI, WC,WHR, WHtR, Fatty liver grade, AST, ALT, GGT, NAFLD fibrosis score , Energy of macronutrients and micronutrients Received

‏In this study, block randomization will be used to create a balance in the number of samples allocated to each of the study groups (supplement and placebo). All blocks will be the same size, and in this two-group experiment, there will be 6 blocks (including 3 participants in the supplement group and 3 participants in the placebo group). Randomization tool, RAS (Random allocation software) is version 2.0 that these random software in addition to simple randomization is also able to block randomization. Thus, 46 eligible patients will be blocked based on age, sex and BMI and will be randomly allocated to the supplement group (propolis) or placebo (cornstarch). Allocation concealment is also used for hiding so that the allocated group is not known before the individual is allocated.

The person in charge of packaging propolis and placebo supplements without knowing the content will determine the type of supplement or placebo that has no role in the implementation and analysis of the study data. None of the researchers or patients will be aware of the type of combination each person is receiving.

Data collected for the primary outcomes will be shared

Access starting 12 months after publication

The data will only be available for people working in academic institutions.

The data of the present study will only be accessible by other researchers , for conducting meta-analysis

Ms.Mahlagha, Nikbaf, E-mail address:mahlaghanikbaf@gmail.com , cellphone number: 00989155122119

The applicant should provide a brief description of the aims and methods of his Meta-analysis . His request will be assessed and , if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.