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

NCT06101433 | Completed

• 1 other identifier: ATehrani
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Keywords

Non-alcoholic fatty liver disease; Isoflavones; Soy foods; FGF21; Liver steatosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• fibroblast growth factor-21 (FGF-21)

  12 weeks

• Fetuin A

  12 weeks

Study Arms (2)

The placebo group

PLACEBO COMPARATOR

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 soy isoflavone group

ACTIVE COMPARATOR

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

Interventions

Soy isoflavone 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.

Also known as: Soyagol

The soy isoflavone group

Placebo 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 placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• consuming less than 90% of intended supplements.
• unwillingness for study collaboration

Sponsors & Collaborators

• Ahvaz Jundishapur University of Medical Sciences: lead

Study Sites (1)

Asal Neshatbini Tehrani

Ahvāz, Khuzestan, 78531-67465, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Asal Neshatbini Tehrani, PhD

  Ahvaz Jundishapur University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and investigator were blinded to study groups (double blinded study)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 26, 2023
• Study Start: September 6, 2022
• Primary Completion: March 12, 2023
• Study Completion: May 11, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Raw data that support the findings of this study are now available from the principal investigator
• Access Criteria: upon reasonable request by contacting the principal investigator

Locations

IR (1)