Back to resultsEffect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
Primary Purpose
Obesity, Childhood, Hepatic Steatosis, Intimal Hyperplasia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
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
Sites / Locations
- CHU Sainte-JustineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyphenol supplementation
Placebo
Arm Description
120mg per day of powder polyphenol for 60 days
1 tab PO QD per day of placebo for 60 days
Outcomes
Primary Outcome Measures
Change in hepatic steatosis MR
MR spectroscopy
Change in hepatic steatosis US Shear wave elastography
US elastography
Change in hepatic steatosis B-mode US
Conventional US
Secondary Outcome Measures
Change in intima media thickness
Measurement of carotid artery intima media thickness
Change in vascular compliance
Non invasive vascular elastography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03994029
Brief Title
Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
Official Title
Effect of Polyphenol Supplementation on Hepatic Steatosis, Non-invasive Vascular Elastography and Intima Media Thickness in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Hepatic Steatosis, Intimal Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polyphenol supplementation
Arm Type
Experimental
Arm Description
120mg per day of powder polyphenol for 60 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tab PO QD per day of placebo for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
Intervention Description
Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness
Primary Outcome Measure Information:
Title
Change in hepatic steatosis MR
Description
MR spectroscopy
Time Frame
At recruitment, after 60 days, and after 120 days
Title
Change in hepatic steatosis US Shear wave elastography
Description
US elastography
Time Frame
At recruitment, after 60 days, and after 120 days
Title
Change in hepatic steatosis B-mode US
Description
Conventional US
Time Frame
At recruitment, after 60 days, and after 120 days
Secondary Outcome Measure Information:
Title
Change in intima media thickness
Description
Measurement of carotid artery intima media thickness
Time Frame
At recruitment, after 60 days, and after 120 days
Title
Change in vascular compliance
Description
Non invasive vascular elastography
Time Frame
At recruitment, after 60 days, and after 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Principal investigator
Phone
5143454931
Email
ramy.el-jalbout.hsj@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramy El Jalbout, MD MSc
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramy El Jalbout, MD
Email
ramy.jalbout@gmail.com
First Name & Middle Initial & Last Name & Degree
Anik Cloutier, MSc
Email
anik.cloutier2.hsj@ssss.gouv.qc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
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