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Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Obesity, Childhood Clinical Trial

Official title:
The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents

Clinical Trial Summary

The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic magnetic resonance imaging and on intima-media thickness and vascular elastography in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy

Clinical Trial Description

1. Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation: Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study 2. Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function 3. Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03994029
Study type Interventional
Source St. Justine's Hospital
Contact Principal investigator
Phone 5143454931
Email ramy.el-jalbout.hsj@ssss.gouv.qc.ca
Status Recruiting
Phase N/A
Start date July 4, 2021
Completion date December 2024
View Details
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