The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
caffeine plus chlorogenic acid
caffeine plus placebo
chlorogenic acid plus placebo
placebo plus placebo
NNFTRI clinic
Tehran, Iran
Hepatic steatosis
measured by CAP score using Fibroscan
Time frame: 6 months
Glucose
Time frame: 6 months
Glycated hemoglobin (HBA1C)
Time frame: 6 months
alanine aminotransferase (ALT)
Time frame: 6 months
aspartate aminotransferase (ALS)
Time frame: 6 months
High sensitive C reactive protein ( hs- CRP)
Time frame: 6 months
gut microbiota
Time frame: 3 months
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