Clinical trial NCT06101433: The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
Official title: The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of Fibroblast Growth Factor-21 and Fetuin A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Keywords: Non-alcoholic fatty liver disease
Isoflavones
Soy foods
FGF21
Liver steatosis
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hepatic histological features by Fibroscan
timeFrame: 12 weeks
measure: The Level of serum liver enzymes
timeFrame: 12 weeks
Secondary outcomes:
measure: fibroblast growth factor-21 (FGF-21)
timeFrame: 12 weeks
measure: Fetuin A
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Asal Neshatbini Tehrani
state: Khuzestan
Study officials:
affiliation: Ahvaz Jundishapur University of Medical Sciences
name: Asal Neshatbini Tehrani, PhD
role: PRINCIPAL_INVESTIGATOR
References: