2.1. Study design
In the present randomized, double-blind, placebo-controlled trial 44
people diagnosed with NAFLD aged 20-60 years participated. Exclusion
criteria were: Pregnant and lactating patients, those with liver
transplantation, smokers, alcohol drinkers and drug users, patients
taking medications such as corticosteroids, amiodarone, tamoxifen,
methotrexate, those with rapid weight loss and diabetes mellitus, heart
failure, renal diseases, hereditary hemochromatosis and Wilson, positive
hepatitis C virus infection, and autoimmune hepatitis were excluded from
the study.
The target population selected from all adult men and women with
non-alcoholic fatty liver referred to gastrointestinal clinic of
Golestan hospital in Ahvaz. . This study was approved by the Ethics
Committee of Ahvaz Jundishapur University of Medical
Sciences (IR.AJUMS.REC.1395.695 ) and was registered in the
Iranian Registry of Clinical Trials website (IRCT ID:
IRCT2017012232109N1). The study goals and protocol were described to the
patient and written informed consent was taken before participating in
the study. Patients were randomly allocated into two groups by block
randomization. Patients and researchers were blinded during the study.
The subjects received NS oil (intervention group) or Paraffin
Oil (placebo group) for 8 weeks. NS oil and paraffin oil soft gel
purchased Barij Essence Company of Kashan. The placebo group received
1gr of paraffin oil soft gel and the intervention group received 1gr of
NS oil soft gel for 8 weeks. Each group received the medication
prescribed by the physician. Anthropometric measurements, including
height, weight, waist and hip circumference were obtained and three days
food record was recorded at the beginning and the last week of the
study. Dietary intake was analyzed by Nutritionist IV software, modified
for Iranian foods.