The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A

NAFLD Clinical Trial

Official title:

The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of Fibroblast Growth Factor-21 and Fetuin A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101433
• Other study ID #: ATehrani
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: October 2023
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 11, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Soy 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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Asal Neshatbini Tehrani	Ahvaz	Khuzestan

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic histological features by Fibroscan	The subject's hepatic histological features using Fibroscan (Echosense, France) assessed at study initiation and at week 12.	12 weeks
Primary	The Level of serum liver enzymes	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	12 weeks
Secondary	fibroblast growth factor-21 (FGF-21)	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.	12 weeks
Secondary	Fetuin A	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.	12 weeks