Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI). The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI. Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
2 symbiotics capsules per day for 28 weeks
2 placebo capsules per day for 28 weeks
NNFTRI clinic
Tehran, Tehran Province, Iran
RECRUITINGAlaninaminotransferase (ALT) (UL)
by biochemical method
Time frame: 28 weeks
hepatic steatosis (cap score)
using transient elastography
Time frame: 28 weeks
Body Mass Index (BMI) (kg/m2)
using formula
Time frame: 28 weeks
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