Effect of soy isoflavones in non alcoholic fatty liver disease

Phase 3

Recruiting

• Conditions: on alcoholic fatty liver disease.; Fatty (change of) liver, not elsewhere classified; K76.0

• Registration Number: IRCT20220801055597N1
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

18-75 years old
Willingness to participate in study
The concentration of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) shall be more than 1.5 fold of the maximum normal level.
With evidence of non alcoholic fatty liver disease in Fibroscan (CAP score>260)
Without a history of alcohol consumption or consuming alcohol less than 10 grams per day in women and less than 20 grams per day in men.
Not taking drugs that affect blood lipids, blood sugar and blood pressure, vitamin E and ursodioxycholic acid (UDCA) and hepatotoxic drugs such as phenytoin, amoxifen, lithium, methotrexate, amiodarone, tamoxifen, corticosteroids, valproate, antiviral drugs, etc. ..
Without a history of other diseases, chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and hereditary disorders affecting the liver (iron or copper storage disease , etc.).
Without a history of celiac disease, diabetes, cardiovascular diseases, lung disease, digestive disease affecting food absorption and kidney disease.
Without a history of weight loss surgery in the past year or a history of adherence to a weight loss diet in the last 6 months
Without a history of thyroid disorder
Not taking fiber and soy supplements in the last 3 months
Without a history of smoking (cigarettes and other tobacco products)
Not regular consumption of soy or soy products in the diet (regular consumption means: consuming more than 30 grams (more than 2 tablespoons) per month)
Without a history of liver cirrhosis or not being classified in F4 group

Exclusion Criteria

Pregnancy and breastfeeding
History of breast cancer
Consuming levothyroxine, warfarin and iron
History of allergy to soy and its products

Study & Design

• Study Type: interventional
• Study Design: Not specified