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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse event

Compliance with polyphenol supplementation

Effectiveness of the data collection procedure during the visits

+4 more

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,969 Total Patients Enrolled

Ramy El Jalbout, MD MScPrincipal InvestigatorSt. Justine's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study restricted to those above a certain age?

"This clinical trial adheres to an age range of 12-18 for participants."

Answered by AI

Is it within my capabilities to become part of this research endeavor?

"This clinical trial is seeking 60 minors between the ages of 12-18 with hyperplasia. To qualify, they must have a BMI higher than 85th percentile for their age and sex, be non-pregnant (if sexually active), and use an efficient form of birth control."

Answered by AI

What is the aggregate of individuals involved in this clinical research?

"Indeed, the facts on clinicaltrials.gov demonstrate that this medical experiment is currently seeking participants. It was initially publicized on June 4th 2021 and has been most recently revised on November 8th 2022. The study requires 60 people from one research centre to partake in it."

Answered by AI

Are there vacancies in this experimental program for participants?

"That is correct. According to clinicaltrials.gov, the trial which was originally published on June 4th 2021 is still recruiting participants and has been recently changed as of November 8th 2022. The team needs 60 individuals from a single centre for this investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Ramy El Jalbout 2021. "Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03994029.

All > Fatty Liver Disease