Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatic Steatosis
- Intimal Hyperplasia
- Obesity, Childhood
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 18 years
- Gender
- Both males and females
Description
Obesity leads to hepatic steatosis. Early changes in vascular compliance due to obesity have been shown to be reversible. Many studies have shown a positive effect of polyphenols (natural product in apples and grapes) on the liver fat burden. Three visits will be planified. Visit 1: Demographic data...
Obesity leads to hepatic steatosis. Early changes in vascular compliance due to obesity have been shown to be reversible. Many studies have shown a positive effect of polyphenols (natural product in apples and grapes) on the liver fat burden. Three visits will be planified. Visit 1: Demographic data and liver and vascular imaging. Blood and stool tests. Randomization to polyphenol versus placebo. Visit 2 at 60 days. Demographic data and liver and vascular imaging. Blood tests. Stop the intervention. Visit 3 at 120 days. Demographic data and liver and vascular imaging. Blood and stool tests. This study will determine the feasibility of a randomized controlled trial evaluating the effect of polyphenols on hepatic steatosis and the vascular subclinical radiologic changes related to obesity.
Tracking Information
- NCT #
- NCT03994029
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ramy El Jalbout, MD MSc St. Justine's Hospital
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