NCT03994029

Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Obesity, Childhood
• Hepatic Steatosis
• Intimal Hyperplasia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness	Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness

Timeline

• Start date: 2021-07-04
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2019-06-21
• Last updated: 2024-01-23

Locations

1 site across 1 country: Canada