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IRCT201511143320N12 IRCT 2015-12-24 Nutrition Research Center, Tabriz University of Medical Scienses The effect of oral alpha-lipoic acid supplement on nonalcoholic fatty liver disease patients The effect of oral alpha-lipoic acid supplement on nutritional status and serum levels of metabolic, oxidative, inflammatory indicators and serum cytokeratin-18 in nonalcoholic fatty liver disease patients 2015-12-22 anticipated 44 Complete https://irct.ir/trial/3408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Daily Oral consumption of 2 capsule contain 600 mg alpha-lipoic acid supplement. Intervention 2: Control group: Daily Oral consumption of 2 capsule contain 600 mg placebo.
public Farshad Amirkhizi
Nutrition Faculty, Attarnayshabouri street, Golgasht street
Tabriz Iran (Islamic Republic of) +98 41 3335 7581 amirkhizif@tbzmad.ac.ir Nutrition Faculty, Tabriz University of Medical Scienses scientific Dr. Mehrangiz Ebrahimi Mamagani
Nutrition Faculty, Attarneyshabouri street, Golgasht street
Tabriz Iran (Islamic Republic of) +98 413335229500 ebrahimimamagani@tbzmed.ac.ir Nutrition Faculty, Tabriz University of Medical Scienses Iran (Islamic Republic of) Inclusion criteria: Desire to participate in the study, confirmation of NAFLD with liver Ultrasonography, aged 20-50 years from both gender, body mass index between 30-40 kg/m2, taking 400IU/day vitamin E, moderate physical activity level Exclusion criteria: Alcohol consumption, smoking, pregnant, lactating and menopausal women, very active subjectes or athletes, hospitalized subjects, suffering from hypertension, cardiovascular diseases, pulmonary diseases, renal diseases, liver transplantation, other acute and chronic liver diseases, biliary system disorders, cancer, Inherited disorders affecting the liver. Receiving Oral Contraceptive Pill (OCP) and antioxidant vitamins unless vitamin E, hypertension and thyroid affecting drugs, statins, inflammation and Insulin sensitivity affecting drugs and Hepatotoxic drugs including phenytoin, amiodarone, levothyroxine, tamoxifen and lithium 20 years 50 years Both K 76 Fatty (change of) liver, not elsewhere classified Other Treatment - Other Intervention group: Daily Oral consumption of 2 capsule contain 600 mg alpha-lipoic acid supplement Control group: Daily Oral consumption of 2 capsule contain 600 mg placebo Hepatic steatosis. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Ultrasound of liver. Liver enzymes (ALP, ALT, AST). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum concentration of these enzymes with enzymatic method by kits. Fasting Blood Sugar (F.B.S.). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method. Serum insulin level. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chemoluminescense. Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Calculation of HOMA-IR. Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Triglyceride, total cholesterol and HDL-cholesterol with spectrophotometry and LDL-cholesterol with Friedewald equation. Oxidative indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Total antioxidant capacity (TAC) by using spectrophotometry, MDA by using thiobarbituric acid, SOD and GPX activities by using ELIZA kits. Inflammatory indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum levels of TNF-α، TGF-β and IL-10 by using ELIZA kits. Sirtuin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit. Fetuin-A. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit. Cytokeratin-18. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit. Added at 2016-01-05: Serum Ferritin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit. Added at 2016-01-05: Serum Adiponectin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit. Added at 2016-01-05: Serum MCP-1 (Monocyte chemoattractant protein-1. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit. Added at 2016-01-05: Serum IL-6. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit. Added at 2016-10-29: Irisin. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: ELIZA kit. Added at 2016-10-29: Plasminogen Activator Inhibitor Factor - 1 (PAI-1. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: ELIZA kit. Added at 2016-10-29: Leptin. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: ELIZA kit. Anthropometric measurements. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Weight and Height by using Seca scale and stadiometer respectively, waist circumference by using tape measure, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters. Energy and macro-nutrients intake. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: 3-day 24 hours food recall. Physical activity level. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: International physical activity questionnaire. Added at 2016-01-05: Body composition (Total body fat, visceral body fat, body water, body bone mass and body muscle mass percentages. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: Bioelectrical impedance analysis machine. Added at 2016-10-29: Appetite status. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Visual Analogue Scales questionnaire. Added at 2016-10-29: Subcutaneous abdominal fat thickness. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Ultrasonography. Nutrition Research Center, Tabriz University of Medical Scienses Approved 2015-12-09 The Research Ethics Committee of Tabriz University of Medical Sciences Attar Neyshabori Street, Tabriz University of Medical Sciences Tabriz Iran (Islamic Republic of)