Evaluation of the effect of high protein-weight loss diet combined with beta cryptoxanthin supplement on nonalcoholic fatty liver disease

Not Applicable

• Conditions: onalcoholic fatty liver disease.; nonalcoholic steatohepatitis

• Registration Number: IRCT2017060210181N10
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 92

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.