Status:
COMPLETED
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
Lead Sponsor:
Ahvaz Jundishapur University of Medical Sciences
Conditions:
NAFLD
Eligibility:
All Genders
18-75 years
Phase:
NA
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-...
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 isof...
Eligibility Criteria
Inclusion
- 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
- consuming less than 90% of intended supplements.
- unwillingness for study collaboration
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06101433
Start Date
September 6 2022
End Date
May 11 2023
Last Update
October 26 2023
Active Locations (1)
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1
Asal Neshatbini Tehrani
Ahvāz, Khuzestan, Iran, 78531-67465