Effect of soy milk consumption on non-alcoholic fatty liver disease.

Effects of soy milk consumption on liver enzymes,lipid profile,glycemic status, markers of inflammation and oxidative stress and hepatic steatosis in non-alcoholic fatty liver patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701162709N40

Enrollment

Registered

2017-02-19

Start date

2017-02-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Control group ) following a 500- calorie deficit diet plan with macronutrients composition of 30 % fat , 15 % protein and 55 % carbohydrate. Intervention 2: Intervention group) The cal

Control group ) following a 500- calorie deficit diet plan with macronutrients composition of 30 % fat , 15 % protein and 55 % carbohydrate

Intervention group) The calorie and macronutrients composition of diet is equal to the control group.In this group, one glass of soy milk ( 240 cc ) is replaced with one serving of both starches and f

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : patient aged 18- 60 y ; diagnosis of NAFLD in accordance to American Gastroenterological Association guidelines as follows: a) hepatic steatosis confirmed by ultrasonography , b) there are no cause for secondary steatosis such as alcohol consumption, hereditary disorders( e.g. hemochromatosis,wilson’s disease) ,autoimmune diseaseses ,hepatotoxic drugs (e.g. methotrexate , amiodaron, tamoxifen, corticosteroids, valproate and anti-viral drugs) and chronic hepatitis C ; Absence of any other co-disorders including but not limited to other chronic liver diseases (hepatitis), cirrhosis, celiac, diabetes, thyroid disorders, breast cysts, as well as cardiovascular, renal, respiratory ,inflammatory and autoimmune diseases ; Absence of cancer or a history of cancer in patient and his/her first-degree relatives ; BMI of 25 to 40 (kg/m2) ; having no allergy to soy milk ; consuming no nutritional supplements during the last two months ; Taking no anti-inflammatory drugs; hasn’t any history of drug abuse and smoking; no pregnancy or lactation ; willingness to participate and sign an informed written consent. Exclusion criteria: Lack of willingness to be a study participants during the study ; allergy or intolerance to soy milk during the study ; Lack of adherence to soy milk consumption ; existence of medical conditions that require special treatments during the study .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Liver enzymes (ALT,AST,ALP,GGT). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery.;Lipid profile (TC,TG,HDL-C). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method.;Serum hs-CRP. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: immunoturbidimetry.;Insulin sensitivity index (QUICKI). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;Fasting blood sugar. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method.;Serum Insulin. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Chemiluminescence immunoassay.;Malondialdehyde. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery.;Insulin resistance (HOMA-IR). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;The ß-cell function ( % HOMA-ß ). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;LDL-C. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;Hepatic steatosis. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: ultrasonography.	—

Measure

Time frame

Liver enzymes (ALT,AST,ALP,GGT). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery.;Lipid profile (TC,TG,HDL-C). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method.;Serum hs-CRP. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: immunoturbidimetry.;Insulin sensitivity index (QUICKI). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;Fasting blood sugar. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: enzymatic method.;Serum Insulin. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Chemiluminescence immunoassay.;Malondialdehyde. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: colorimetery.;Insulin resistance (HOMA-IR). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;The ß-cell function ( % HOMA-ß ). Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;LDL-C. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.;Hepatic steatosis. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: ultrasonography.

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Secondary

Measure	Time frame
Systolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer.;Diastolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer.;Plasma fibrinogen. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: clauss method.;Weight. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Seca scale.;Waist circumference. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: elastic tape.;Body mass index. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.	—

Measure

Time frame

Systolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer.;Diastolic blood pressure. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: mercury sphygmomanometer.;Plasma fibrinogen. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: clauss method.;Weight. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: Seca scale.;Waist circumference. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: elastic tape.;Body mass index. Timepoint: before the experiment and 8 weeks after intervention. Method of measurement: formula.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farzad Shidfar

Iran University of Medical Sciences

farzadshidfar@yahoo.com+98 21 8862 2755

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026