NAFLD
Conditions
Keywords
Non-alcoholic fatty liver disease, Isoflavones, Soy foods, FGF21, Liver steatosis
Brief summary
In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed at study initiation and after week 12.
Interventions
DIETARY_SUPPLEMENTSoy isoflavone
the subjects in the soy isoflavone group were told to take 2 drugs per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.
OTHERPlacebo
the subjects in the placebo group were told to take 2 placebo tablets per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.
Sponsors
Ahvaz Jundishapur University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participants and investigator were blinded to study groups (double blinded study)
Intervention model description
Patients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years or older * without any history of allergy to soy or excessive consumption of soy products * without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent; * hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP \> 260 dB/m); * without history of excessive alcohol drink (≥10 g/day); * without history of drug consumption with approved positive effects on NAFLD treatment (i.e. metformin, vitamin E, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months; * without the history of bariatric surgery or following weight loss diets within 6 months; * without history of smoking; * not being a pregnant or lactating woman
Exclusion criteria
* consuming less than 90% of intended supplements. * unwillingness for study collaboration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic histological features by Fibroscan | 12 weeks | The subject's hepatic histological features using Fibroscan (Echosense, France) assessed at study initiation and at week 12. |
| The Level of serum liver enzymes | 12 weeks | The serum levels of alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT) measured through enzymatic methods by Delta Darman Part test kits (Delta darman part, Tehran, Iran) at study initiation and at the end of the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fibroblast growth factor-21 (FGF-21) | 12 weeks | The serum level of FGF-21 measured via ELISA commercial kits (ZellBio GmbH Veltlinerweg 29, 89075, Ulm, Germany) at study initiation and at week 12. |
| Fetuin A | 12 weeks | The serum level of fetuin A measured via ELISA commercial kits (ZellBio GmbH Veltlinerweg 29, 89075, Ulm, Germany) at study initiation and at week 12. |
Countries
Iran
Outcome results
None listed