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

Sponsor

Ahvaz Jundishapur University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT06101433

Collaborator

(none)

Enrollment

Location

Arms

8.1

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD	Dietary Supplement: Soy isoflavone Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeksPatients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeks

Masking:

Double (Participant, Investigator)

Masking Description:

The participants and investigator were blinded to study groups (double blinded study)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 6, 2022

Actual Primary Completion Date :

Mar 12, 2023

Actual Study Completion Date :

May 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: The placebo group 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.	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.
Active Comparator: The soy isoflavone group 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.	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 Names: Soyagol

Arm

Intervention/Treatment

Placebo Comparator: The placebo group

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.

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.

Active Comparator: The soy isoflavone group

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.

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 Names:

Soyagol

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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