Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Sponsor

St. Justine's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03994029

Collaborator

(none)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood Hepatic Steatosis Intimal Hyperplasia	Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness	N/A

Detailed 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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Polyphenol Supplementation on Hepatic Steatosis, Non-invasive Vascular Elastography and Intima Media Thickness in Obese Adolescents

Actual Study Start Date :

Jun 4, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polyphenol supplementation 120mg per day of powder polyphenol for 60 days	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
Placebo Comparator: Placebo 1 tab PO QD per day of placebo for 60 days	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

Arm

Intervention/Treatment

Experimental: Polyphenol supplementation

120mg per day of powder polyphenol for 60 days

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

Placebo Comparator: Placebo

1 tab PO QD per day of placebo for 60 days

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

Outcome Measures

Primary Outcome Measures

Change in hepatic steatosis MR [At recruitment, after 60 days, and after 120 days]
MR spectroscopy
Change in hepatic steatosis US Shear wave elastography [At recruitment, after 60 days, and after 120 days]
US elastography
Change in hepatic steatosis B-mode US [At recruitment, after 60 days, and after 120 days]
Conventional US

Secondary Outcome Measures

Change in intima media thickness [At recruitment, after 60 days, and after 120 days]
Measurement of carotid artery intima media thickness
Change in vascular compliance [At recruitment, after 60 days, and after 120 days]
Non invasive vascular elastography

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adolescents 12-< 18
Residing in the Montreal area
BMI > 20-24Kg/m² (> 85th percentile for age and sex)
Hepatic MRI spectroscopy showing ratio > 5.5% lipid/water
Not being pregnant (if sexually active, using an effective contraceptive method)

Exclusion Criteria:

chronic disease, including diabetes, hypercholesterolemia, hypertension, hepatitis (viral and autoimmune), Wilson's disease and Alpha 1 antitrypsin.
Taking medications or supplements
Having a significant weight loss in the last 6 months prior to recruitment
Alcohol consumption > 2 drinks per day or consume more than 1 day per week
Known peanut allergies
Contraindications for MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T1C5

Sponsors and Collaborators

St. Justine's Hospital

Investigators

Principal Investigator: Ramy El Jalbout, MD MSc, St. Justine's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramy El Jalbout, Assistant professor, St. Justine's Hospital

ClinicalTrials.gov Identifier:

NCT03994029

Other Study ID Numbers:

2019-2278

First Posted:

Jun 21, 2019

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Pediatric Obesity

Hyperplasia

Study Results

No Results Posted as of Jun 8, 2021