nonalcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention1: calorie restriction diet for 3 months. Intervention 2: Intervention 2: 2 capsules daily each contains 300 mg of trans resveratrol for 3 months. Intervention 3: placebo:
Lifestyle
Treatment - Drugs
Placebo
Intervention1: calorie restriction diet for 3 months
Intervention 2: 2 capsules daily each contains 300 mg of trans resveratrol for 3 months
placebo: 2 capsules daily each contains 300 mg of starch for 3 months
Sponsors
Nutrition Research Center, vice-chancellor of Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age between 20 to 60 years from both gender; diagnosed with nonalcoholic fatty liver disease based on liver Ultrasonography; BMI=25-35; willingness to participate in the study. Exclusion criteria: pregnancy; breast feeding and postmenopausal women; professional athletes; smoking; alcohol consumption; following weight-reducing diet 3 months prior to the study; known liver disease (viral/etc.); inherited disorders affecting the liver; history of diagnosed cardiovascular, kidney, diabetes, gastrointestinal, pulmonary and autoimmune diseases, thyroid dysfunction and active cancer; recent surgery; use of medications such as corticosteroids, hepatotoxic drugs, hormonal drugs (such as oral contraceptive and/or estrogens), antidepressants and psychotropic medications, anticoagulant drugs, oral anti-diabetic and lipid-lowering drugs. Receiving any kinds of supplements 3 months prior to the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver echogenicity. Timepoint: Baseline and after the intervention. Method of measurement: Sonographic findings.;Lipid profile (TC, TG, LDL-C, HDL-C, APO-A1, APO-B). Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Fasting blood glucose. Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Insulin. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Baseline and after the intervention. Method of measurement: HOMA-IR.;Oxidative status (TAC, MDA, GPx, SOD, Ox-LDL). Timepoint: Baseline and after the intervention. Method of measurement: Biochemical.;Sirtuin-1. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Fibroblast growth factor-21. Timepoint: Baseline and after the intervention. Method of measurement: ELISA.;Added at 2016-11-15: Plasminogen activator inhibitor-1 (PAI-1. Timepoint: Added at 2016-11-15: Baseline and after the intervention. Method of measurement: Added at 2016-11-15: ELISA.;Added at 2016-11-15: hs-CRP. Timepoint: Added at 2016-11-15: Baseline and after the intervention. Method of measurement: Added at 2016-11-15: Imonotorbidometry.;Liver enzymes (ALT, AST, GGT, ALP). Timepoint: Baseline and after the intervention. Method of measurement: Spectrophotometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic and diastolic blood pressure. Timepoint: Baseline and after the intervention. Method of measurement: Manometer.;Anthropometric measurements (BMI, WHR, WC). Timepoint: Baseline and after the intervention. Method of measurement: Secca scale, non stretch meter.;Energy and nutrient intake. Timepoint: Baseline, end of week 6 and after the intervention. Method of measurement: 3-day food record questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSomayyeh Asghari
Tabriz University of Medical Sciences
Outcome results
None listed