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

NCT ID: NCT06101433

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-05-11

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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Soy isoflavone

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Soyagol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahvaz Jundishapur University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Asal Neshatbini Tehrani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asal Neshatbini Tehrani, PhD

Role: PRINCIPAL_INVESTIGATOR

Ahvaz Jundishapur University of Medical Sciences

Locations

Asal Neshatbini Tehrani

Ahvāz, Khuzestan, Iran

Countries

Iran

Other Identifiers

ATehrani

Identifier Type: -

Identifier Source: org_study_id