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IRCT2017060210181N10 IRCT 2017-06-20 Ahvaz Jundishapur University of Medical Sciences Evaluation of the effect of high protein-weight loss diet combined with beta cryptoxanthin supplement on nonalcoholic fatty liver disease Evaluation of the effect of high protein-weight loss diet combined with beta cryptoxanthin supplement on metabolic factors, serum levels of oxidants, inflammatory and adipocytokins among patients with nonalcoholic fatty liver disease. 2017-09-23 anticipated 92 Complete https://irct.ir/trial/10645 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Nonalcoholic fatty liver disease. 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 months. Intervention 2: 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 3: 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. Intervention 4: 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.
public Dr. Fatemeh Heidari
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8330 Haidari58@gmail.com Ahvaz Jundishapur University of Medical Science scientific Dr. Fatemeh Heidari
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science Ahvaz
Ahvaz Iran (Islamic Republic of) +98 61 3373 8330 Haidari58@gmail.com Ahvaz Jundishapur University of Medical Science Iran (Islamic Republic of) 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. 18 years 60 years Both k75.8 nonalcoholic steatohepatitis Lifestyle Lifestyle Lifestyle 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 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. 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. γ-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. Ahvaz Jundishapur University of Medical Sciences Approved 2017-05-20 Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences Ahvaz Iran (Islamic Republic of)