The effect of supplementation with pomegranate peel extract on liver enzymes, hs-CRP and lipid profile in patients with non-alcoholic fatty liver disease: a randomized, double-blind clinial trial.

effect of supplementation with pomegranate peel extract on liver enzymes, hs-CRP and lipid profile in patients with NAFLD.

A 10-week randomized, double-blinded, parallel clinical trial on 46 patients with NAFLD.

Patients are randomly divided into intervention and placebo groups . A written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for weight loss will be given to each patients. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken at the beginning and end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.

Liver enzyme(ALT) greater than 20 IU/L for women and greater than 30 IU/L for men. Evidence of fatty liver in ultrasonography with a score of 1 or 2. Being volunteer to attend. age: 30 to 60 years. BMI: 25 to 35. Exclusion criteria: Other acute or chronic hepatic disorders cardiovascular disease, renal disease, infectious disease, diabetes, cancer. hemorrhoid or chronic constipation. intensive weight loss or weight gain during 3 months prior to intervention. Any use of antioxidant supplements or hepatotoxic medications during one month prior to intervention. Use of lipid lowering or insulin-sensitizing medications. Problem in blood coagulation. Dysmenorrhea. excessive bleeding during menses. History of benign tumours. pregnancy. lactation.

Intervention group: 2 capsules of pomegranate peel extract daily. placebo group: 2 starch capsules daily.

Serum levels of ALT and AST are the main outcomes of the study. Other variables include total cholesterol, triglycerides, HDL-C, LDL-C, alkaline phosphatase and hs-CRP.

By random allocation participants will divide into intervention and placebo groups each of which consist of 23 patients. Since The results of biochemical tests varies in age range from 30 to 60 and it can affect the result of the intervention and to make sure about the equal distribution of variables among groups, randomization is done in a randomized, stratified method based on the age. A randomized list is produced and randomization will be done based on the age by relevant list.

pomegranate extract capsules and placebo capsules are similar in appearance, weight and packaging. individual codes will be used on the packaging.

There is no further information

Information on the main implications can be shared at the end of the study.

The access period will be 6 months after the results are published.

The data from this study will be available only to researchers working in academic and scientific institutions.

6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.

Applicants can contact the responsible author via email or the following mailing address to obtain the required data. Postal address: Tehran-Hemmat Highway-Iran University of Medical Sciences-Faculty of Health-Department of Nutrition. Contact number: 00982188622755. Email: shidfar.f@iums.ac.ir

Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.