Nonalcoholic fatty liver disease. nonalcoholic steatohepatitis
Conditions
Interventions
Intervention 1: Intervention group1 : reduction of calorie intake by 500 K cal/day and diet with 30% fat, 25% protein, and 45% carbohydrates (high-protein diet) plus 6 mg beta crypthxanthin for 3 mon
Lifestyle
Intervention group1 : reduction of calorie intake by 500 K cal/day and diet with 30% fat, 25% protein, and 45% carbohydrates (high-protein diet) plus 6 mg beta crypthxanthin for 3 months
Intervention group 2: reduction of calorie intake by 500 K cal/day and diet with 30% fat, 25% protein, and 45% carbohydrates (high-protein diet) plus placebo for 3 months
Intervention group 3 : reduction of calorie intake by 500 K cal/day and diet with 30% fat, 15% protein, and 55% carbohydrates ( normal protein diet ) plus 6 mg beta cryptoxanthin for 3 months
Control group : reduction of calorie intake by 500 K cal/day and diet with 30% fat, 15% protein, and 55% carbohydrates ( normal protein diet ) plus placebo for 3 months
Sponsors
Ahvaz Jundishapur University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria will be included: subjects will be overweight and obese (25=BMI =40) individuals aged between 18–60 years of both genders, existence of NAFLD by ultrasound, NAFLD activity score less than 3, and willingness to participate. subjects with viral hepatitis, cirrhosis, Wilson's disease, acute fatty liver of pregnancy, hepatocellular carcinoma, hypothyroidism and a history of chronic liver disease, lipodystrophy, menopause, parenteral nutrition, bladder and bile duct disease, significant weight loss (=10% of body weight during 6 months ago) or weight loss surgery, Congenital metabolic diseases, subjects on antioxidant supplementations, milk thistle and omega-3 fatty acids in the 6 months ago, a history of liver damaging drugs (amiodarone, anti-virus, aspirin, non-steroidal anti-inflammatories, corticosteroids, methotrexate, tamoxifen, tetracycline, valproic acid), alcohol consumption >20 g/day, calorie intake less than 800 kcal or more than 4200 a day, pregnancy and lactation, serum ALT levels more than five times of the upper limit (maximum limit of 30 for women and 40 for men), history of cardiovascular and kidney disease (urine analysis Albumina = 30 (mg / 24 h) and GFR = 90 ml / min / 1.73 m2) will be not included.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma insulin. Timepoint: before intervention and after 3 months intervention. Method of measurement: colorimetry.;Free fatty acids. Timepoint: before intervention and after 3 months intervention. Method of measurement: Eliza.;Serum beta cryptoxanthin. Timepoint: before intervention and after 3 months intervention. Method of measurement: HPLC- C18.;Serum adiponectin. Timepoint: before intervention and after 3 months intervention. Method of measurement: Eliza.;High sensitive-C-reactive protein (CRP). Timepoint: before intervention and after 3 months intervention. Method of measurement: Eliza. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: before intervention and after 3 months intervention. Method of measurement: electronic scale (Beurer PS160, Germany).;BMI. Timepoint: before intervention and after 3 months intervention. Method of measurement: weight (kg)/height2 (m2).;Body fat mass. Timepoint: before intervention and after 3 months intervention. Method of measurement: Bioelectrical impendence analysis (BIA).;LDL. Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;HDL. Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Total cholesterol. Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Triglyceride. Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Fasting blood sugar. Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Aspartate aminotransferase (AST). Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Alanine aminotransferase (ALT). Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;?-glutamil transferase (GGT). Timepoint: before intervention and after 3 months intervention. Method of measurement: Enzymetic method.;Malondialdehyde (MDA). Timepoint: before intervention and after 3 months intervention. Method of measurement: Satoh.;Model-insulin resistance index (HOMA-IR). Timepoint: before intervention and after 3 months intervention. Method of measurement: HOMA= fasting serum insulin (µU/ml)× fasting plasma glucose (mM/L)/22.5.;HbA1c. Timepoint: before intervention and after 3 months intervention. Method of measurement: spectrophotometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Fatemeh Heidari
Ahvaz Jundishapur University of Medical Science
Outcome results
None listed