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

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Other: Placebo; Dietary Supplement: Soy isoflavone

• Registration Number: NCT06101433
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

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.

Study Timeline

• Study Start: 2022-09-06
• Primary Completion: 2023-03-12
• Study Completion: 2023-05-11
• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The placebo group	Placebo	Subjects in the placebo group, were advised to take two placebo tablets per day for 12 weeks along with life style modification such as physical activity of 30 minutes for 3 days per week with medium intensity and food intake consults provided by clinical guidelines of NIH and the North American Association for the Study of Obesity. The placebo tablets contained starch and they were similar to the soy isoflavone tablets in smell, taste, and appearance. The placebo tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran.
The soy isoflavone group	Soy isoflavone	In the soy isoflavone group, patients took 100 mg soy isoflavone in the form of two tablets per day for 12 weeks along with lifestyle modification. Each soy isoflavone 50 mg tablet contained 1.49 mg of genistein, 31.86 mg of genistin, 1.75 mg of daidzein, 13.21 mg of daidzin, 0.55 mg of glycitein and 1.14 mg of glycitin. The soy isoflavone tablets were made by Gol Daru Pharmaceutical Company, Isfahan, Iran.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Asal Neshatbini Tehrani; 🇮🇷 Ahvaz, Khuzestan, Iran, Islamic Republic of