| Trial ID: | L0596 |
| Source ID: | IRCT201511143320N12
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| Associated Drug: |
Alphalipoic acid
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| Title: |
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
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
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| Interventions: |
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.;Treatment - Other;Intervention group: Daily Ora
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| Outcome Measures: |
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-a? TGF-?? 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.
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| Sponsor/Collaborators: |
Nutrition Research Center, Tabriz University of Medical Scienses
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| Gender: |
All
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| Age: |
20 years50 years
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| Phases: |
Not applicable
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| Enrollment: |
44
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
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| Start Date: |
24/12/2015
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
22 February 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/3408
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