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Polyphenol Supplement

Polyphenol Supplementation for Fatty Liver Disease

N/A
Recruiting
Led By Ramy El Jalbout, MD MSc
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents 12-< 18
BMI > 20-24Kg/m² (> 85th percentile for age and sex)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year

Summary

This trialstudies how polyphenol supplements affect liver fat in obese adolescents with liver fat buildup, diagnosed with liver biopsy.

Who is the study for?
This trial is for obese adolescents aged 12-17 in Montreal with a BMI >20-24Kg/m² and diagnosed fatty liver disease by hepatic MRI. Participants must not be pregnant, have chronic diseases like diabetes or hypertension, consume significant alcohol, have had recent weight loss, peanut allergies, or take certain medications.
What is being tested?
The study examines the effects of polyphenol supplements on fatty liver (hepatic steatosis) using ultrasound and MRI scans. It also looks at changes in blood vessel health through intima-media thickness and vascular elastography measurements.
What are the potential side effects?
While the side effects are not explicitly listed here, polyphenols are generally considered safe but may cause mild digestive issues or allergic reactions in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 17 years old.
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My BMI is above the 85th percentile for my age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse event
Compliance with polyphenol supplementation
Effectiveness of the data collection procedure during the visits
+4 more
Secondary study objectives
Anthropometric measure
Change in hepatic steatosis B-mode US
Change in hepatic steatosis MR
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Polyphenol supplementationExperimental Treatment1 Intervention
120mg per day of powder polyphenol for 60 days
Group II: PlaceboPlacebo Group1 Intervention
1 tab PO QD per day of placebo for 60 days

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
85,780 Total Patients Enrolled
Ramy El Jalbout, MD MScPrincipal InvestigatorSt. Justine's Hospital
~0 spots leftby Dec 2024
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