Clinical Trial Details

Trial ID: L0500
Source ID: IRCT20180412039284N1
Associated Drug: Chitosan
Title: The effect of chitosan supplementation on changes of body weight, glycemic risk factors (fasting glucose, insulin, glycated hemoglobin), lipid profile and visceral adiposity index in patients with nonalcoholic fatty liver disease (NAFLD)
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic fatty liver. <br>Nonalcoholic fatty liver disease [NAFLD]
Interventions: Intervention 1: Intervention group: 1000 miligram of chitosan supplement (chitosan dose:500 miligram; twice a day). Intervention 2: control group: 1000 miligram placebo.
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.;LDL. Timepoint: Before the intervention and twelve weeks after. Method of measurement: enzymatic method.;HDL. 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 mehod.Weight. Timepoint: before the intervention and 12 weeks after. Method of measurement: scale (seca).;BMI. Timepoint: before the intervention and 12 weeks after. Method of measurement: weight (kg) divided to height square.;Visceral adiposity index. Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: enzymatic method.;Alanine aminotransferase (ALT). Timepoint: before the intervention and 12 weeks after. Method of measurement: enzymatic method.;Model-insulin resistance index (HOMA-IR). Timepoint: before the intervention and 12 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 12 weeks after. Method of measurement: BIA.
Sponsor/Collaborators: Ahvaz University of Medical Sciences
Gender: All
Age: 18 years65 years
Phases: Not applicable
Enrollment: 50
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sampl
Start Date: 09/05/2018
Completion Date: --
Results First Posted: --
Last Update Posted: 18 June 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/30682