Clinical Trial Details

Trial ID: L0774
Source ID: IRCT20150124020765N2
Associated Drug: Cranberry
Title: Effect of combined dietary weight loss and cranberry supplementation on hepatic enzymes, steatosis and inflammatory, antioxidant and apoptosis biomarkers in patients with Non-alcoholic fatty liver disease
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Intervention group: dietary weight loss and 2 capsules containing 288 mg Cranberry extract for 12 weeks. Intervention 2: Control group: dietary weight loss and 2 placebo capsules for 12 weeks.
Outcome Measures: Fatty liver grade (Steatosis). Timepoint: At baseline and after 12 weeks. Method of measurement: ultrasonography.;Alanine transaminase. Timepoint: At baseline and after 12 weeks. Method of measurement: enzymatic colorimetric assay.;Aspartate aminotransferase. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Alkaline phosphatase. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Monocyte chemoattractant protein 1 (Mcp-1)) ?? CCL2. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Ytokeratin-18. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Total antioxidant body. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Malondialdehyde. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Tumor necrosis factor alpha. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Lipid profile. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa kit.;Insulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Elisa.;Fasting blood sugar. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzymatic colorimetric assay.nan
Sponsor/Collaborators: Ahvaz University of Medical Sciences
Gender: All
Age: 18 yearsno limit
Phases: Phase 3
Enrollment: 50
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study; we assume equal allocation of subjects to each group With blocked randomization. With a randomized bl
Start Date: 06/01/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 29 January 2019
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/36005