metabolic associated fatty liver disease. 'Fatty (change of) liver, not elsewhere classified (non-alcoholic fatty liver disease)'
Conditions
Interventions
Intervention 1: Intervention group: Along with lifestyle interventions (diet therapy + physical activity), supplementation with Akkermansia muciniphila (10 to the power of 10) is given for 12 weeks. O
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 65 years Diagnosed hepatic steatosis (based on liver enzyme levels and ultrasound imaging results performed by a skilled and experienced sonographer and with the opinion of a gastroenterologist and hepatologist) plus one of the following three: obesity or overweight (BMI>25), type 2 diabetes (HGB A1C >6.5% or taking antidiabetic medication), healthy weight individuals (BMI102 cm in men and >88 cm in women, blood pressure >130/85 or taking blood pressure-lowering medication, plasma triglycerides >150 mg or taking blood-lipid-lowering medication, HDL <40 mg/dL in women and <50 mg/dL in men or taking medication, prediabetes (fasting blood sugar 100 to 125 mg/dL or two-hour blood sugar 140 to 199 or HgbA1C 5.7% to 6.4%), HOMA greater than 2.5, CRP greater than 2 mg/dL
Exclusion criteria
Exclusion criteria: Pregnant, lactating women or those planning to become pregnant in the next three months. Elevated liver enzymes Morbid obesity (body mass index greater than 40) History of alcohol consumption greater than 10 grams per day for women and greater than 20 grams per day for men (for more than three consecutive months per year) or smoking People with pathological conditions affecting the liver, including acute and chronic hepatitis, viral hepatitis, liver transplantation, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis or Wilson's disease, antitrypsin deficiency. Cushing's syndrome, any immune-compromising disorder including: autoimmune disorders, cancer, ITP to human immunodeficiency virus History of cardiovascular disease (except hypertension), cancer, mental illness, severe liver or kidney dysfunction; Thyroid diseases such as goiter, hypothyroidism or hyperthyroidism Long-term use of estrogen or regular use of drugs associated with fatty liver disease, such as corticosteroids, methotrexate, tamoxifen and amiodarone, sodium valproate Consumption of supplements effective on fatty liver such as vitamin E, omega-3 supplements Use of any probiotic products within the past two months Received antibiotic treatment one month before entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver enzymes including alanine aminotransferase and aspartate aminotransferase. Timepoint: Before and at the end of the intervention (beginning of the study and at the end of the third month). Method of measurement: laboratory methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of anthropometric indicators (height, weight, body mass index, waist circumference). Timepoint: Before and at the end of the intervention. Method of measurement: Scale with an accuracy of 100 grams, meters.;Blood pressure. Timepoint: Before and at the end of the intervention. Method of measurement: Digital blood pressure monitor.;HGB A1c. Timepoint: Before and at the end of the intervention. Method of measurement: laboratory kit.;C-reactive protein. Timepoint: Before and at the end of the intervention. Method of measurement: laboratory methods.;Lipid profile (triglycerides and high-density lipoprotein). Timepoint: Before and at the end of the intervention. Method of measurement: laboratory methods.;Insulin and fasting plasma glucose. Timepoint: Before and at the end of the intervention. Method of measurement: laboratory methods.;Measurement of body composition (fat mass and fat free mass) using a BIA device. Timepoint: Before and at the end of the intervention. Method of measurement: BIA.;Assessment of the IPAQ physical activity questionnaire and dietary recall. Timepoint: Before, during, and at the end of the study. Method of measurement: statiscal methods. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParastoo Asghari
Mashhad University of Medical Sciences
Outcome results
None listed