| Trial ID: | L0492 |
| Source ID: | IRCT20180412039284N2
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| Associated Drug: |
chitosan
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| Title: |
The effect of chitosan supplementation on changes of weight, glycemic risk factors, lipid profile, serum inflammatory factors, adipokines and total antioxidant capacity in patients with nonalcoholic fatty liver disease (NAFLD)
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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: |
Nonalcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention 1: Intervention group: Consumption of chitosan (dose of supplements: 500 miligram) twice a day (one before lunch and one before dinner) for 12 weeks. Chitosan supplements are provided by Karen company. Intervention 2: Control group: Consumpt
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| Outcome Measures: |
Glycated hemoglobin A1c. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Spectrophotometry.;Fasting blood glucose. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Plasma insulin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Calorimetry.;Serum adiponectin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Serum leptin. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Interleukin-6. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;TNF-alpha. Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;Serum total antioxidant capacity (TAC). Timepoint: Before the intervention and twelve weeks after. Method of measurement: ELISA.;High Density Lipoprotein (HDL). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Low Density Lipoprotein (LDL). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Total cholesterol. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Triglyceride. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.Weight. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Scale (seca).;Body Mass Index (BMI). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Weight (kg) divided to height square.;Visceral Adiposity Index. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Formula based on these variables: BMI, waist circumference, HDL-C and triglyceride (TG).;Aspartate aminotransferase (AST). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Alanine aminotransferase (ALT). Timepoint: Before the intervention and twelve weeks after. Method of measurement: Enzymatic method.;Model-insulin resistance index (HOMA-IR). Timepoint: Before the intervention and twelve weeks after. Method of measurement: HOMA= fasting serum insulin (??U/ml)?? fasting plasma glucose (mM/L)/22.5.;Body fat percentage. Timepoint: Before the intervention and twelve weeks after. Method of measurement: Bioelectrical Impedance Analysis (BIA).
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| Sponsor/Collaborators: |
Ahvaz University of Medical Sciences
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| Gender: |
All
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| Age: |
18 years65 years
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| Phases: |
Not applicable
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| Enrollment: |
50
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, a nonrandom sample is chosen among the individuals ,who has the inclusion criteria, using a simple sampling met
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| Start Date: |
19/07/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
11 September 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/31974
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