Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Supplementation of 500 mg of fennel extract (manufactured by Zardband Company) once a day for 12 weeks. Intervention 2: Control group: 500 mg placebo supplement onc
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patient consent to participate in the study Age between 18 years and 65 years BMI between 25 and 35 kg/m2 Diagnosis of disease based on the criteria of the American Society of Gastroenterology and Hepatology and confirmation by a specialist doctor Grade 1 and 2 hepatic steatosis in ultrasonography of patients
Exclusion criteria
Exclusion criteria: Having any other acute or chronic liver disease Having thyroid disorders, severe hormonal disorders, cancer, asthma, and known autoimmune diseases Taking medications that affect weight, fat, and blood sugar Use of corticosteroids, NSAIDs (ibuprofen, aspirin, and diclofenac), and anti-TNF drugs (Cinnura or Adalimumab, Infliximab, or Remicade) Taking any medication containing sex hormones History of significant weight loss or gain within the past 3 months Any disturbance in the menstrual cycle of women Use of any multivitamin, omega-3, or phytoestrogen supplements within the past 2 months Drug abuse Pregnancy and breastfeeding History of any hormonal cancers or ovarian, uterine, or breast cysts in the individual or first-degree family members History of allergy to fennel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressue. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: Blood pressure will be measured at the beginning and end of the study. To do this, patients will be at complete rest for 5 minutes. After 5 minutes, blood pressure will be measured twice on the patient's right arm with an Omron digital upper arm blood pressure monitor (made in Japan) at least 30 seconds apart and the average will be recorded.;Inflammatory factor IL-6. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: ELISA test.;Glycemic indices. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: Glycemic indices including FBS and Insulin will be examined by calorimetric and quantitative luminescence methods, respectively. Insulin resistance will be calculated through HOMA-IR index according to the following formula:HOMA-IR : Fasting glucose (m mol /l)* Fasting insulin (µU/ml) / 22.5Insulin sensitivity will also be calculated in this study through QUICKI index according to the following formula:QUICKI: [log fasting glucose (mg/dL) + log fasting insulin (µU/mL)] -1.;Lipid profile. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: TG, HDL-C, and TC concentrations will be measured calorimetrically, and LDL-C concentrations will be calculated using the Friedewald formula.LDL-C (mg/dL) = TC (mg/dL) - HDL-C (mg/dL) – (TG (mg/dL)/5).;Liver enzymes. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: Measurement of liver enz | — |
Secondary
| Measure | Time frame |
|---|---|
| FLI. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention). Method of measurement: Fatty liver index predicts hepatic steatosis through calculation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Shidfar
Iran University of Medical Sciences
Outcome results
None listed