The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.

The aim of this study was to evaluate the effect of portulaca oleracea (purslane) hydroalcoholic extract in patients with non-alcoholic fatty liver disease (NAFLD).

A 12-week randomized, double-blinded, parallel clinical trial on 74 patients with NAFLD.

Patients are randomly divided into intervention and placebo groups (37 patients in each group). The study process is described for each patient and a written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound once at the beginning and again at week 12 of the study. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for 10% weight loss will be provided to each patients individually by a nutritionist. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken from patients at the beginning and at end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.

Men and women with non-alcoholic fatty liver disease whose ALT is greater than 30 U / l and more than 19 U / L, respectively, and who do not have chronic liver disease, cardiovascular disease, hypertension, or kidney stones are eligible to participate in the study.

Intervention group: one capsule containing 300 mg of purslane hydroalcoholic extract daily. Placebo Group: A capsule daily similar in appearance to drug capsules, filled with toasted powder.

Serum levels of ALT and AST are the main outcomes of the study. Other variables include fasting blood glucose, insulin, total cholesterol, triglycerides, HDL-C, LDL-C, gamma glutamyl transferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectin, NF-kB and expression of the NF-κB gene.

1. Submission of information in the old version of IRCT 2. Creating some changes in the sample size after the approval of the Vice Chancellor for Research of Iran University of Medical Sciences 3. Correcting the secondary outcome variables

Vice Chancellor for Research of Iran university of Medical Sciences

Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.com. In order to conceal in the randomization process, unique codes have been used on the medicine boxes, which are produced by the software.

In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the software.

There is no further information

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

The access period will be 6 months after the publication of the results.

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

Six months after the publication of the articles of this project, upon request from the corresponding author and his agreement, the study data can be made available to researchers.

Applicants can contact the corresponding author via email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highsway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com

Applicants will be able to access the data from the present study no later than one week by sending an email to the corresponding author.