The effect of grape seed extract supplementation on glycemic status, lipid profile, plasma atherogenic index, liver enzymes, anthropometric indices and some inflammatory and antioxidant indices in overweight and obese patients with nonalcoholic fatty liver disease

Evaluation of the effect of grape seed extract on biochemical and anthropometric factors in patients with non-alcoholic fatty liver

Clinical trials phase 2, two parallel groups, double-blind, randomized.

It is performed in the clinic of Shohada hospital in Hindijan. Researchers and patients are blinded.

Inclusion criteria: 20-60 years old patient with non alcoholic fatty liver disease; BMI equal to 25-30. Exclusion criteria: patients who have diabetes, cardiovascular, kidney and other hepatic diseases; pregnant or lactating women; smoking; alcohol consumption; use of dietary supplements

Treatment group: Receiving grape seed extract 500 mg daily. Control group: receiving placebo.

Changes in biochemical factors (HDL, LDL, ALT, AST, triglyceride, cholesterol, plasma atherogenic index, total antioxidant capacity, interleukin 6, fasting blood sugar, HbA1c, fasting insulin level, weight, body mass index, waist circumference)

The present study is a simple randomized clinical trial on subjects with fatty liver. In this study, individuals are divided into two groups of drugs and placebo. The method of assigning subjects to each group is that individuals are assigned every other one.

First, researchers will explain the study to the participants. This study is a triple-blind study. The two groups, medications and placebo, receive completely similar capsules, and they do not know the contents of the capsule. The statistical analyzer is not informed about the groups. Also, the therapist will not know about the intervention groups.

All data can be shared after the participants in the study are unrecognizable.

The data access period after printing the article.

The data in this study will be available to researchers working at academic and scientific institute.

Any analysis can be done with the consent of the main researcher.

Hamidreza Razmi

The researcher or pharmaceutical company can send their request to the email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.