Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Launched by ST. JUSTINE'S HOSPITAL · Jun 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called polyphenol on certain health issues in obese adolescents, particularly those with a condition known as hepatic steatosis, which is when too much fat builds up in the liver. Researchers want to see if taking this supplement can improve liver health and blood vessel function. The trial will use tests like ultrasounds and MRIs to measure changes in the liver and blood vessels over time.

To participate, adolescents aged 12 to 18 years who are considered obese (above the 85th percentile for their age and sex) and have been diagnosed with hepatic steatosis through imaging or liver biopsy may be eligible. Participants should also have elevated liver enzyme levels. During the trial, participants will take the polyphenol supplement and undergo regular health assessments. It's important to note that certain conditions, like chronic illnesses or recent significant weight loss, may exclude individuals from joining the study. If you're interested or have questions, please speak with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 12 to 18 years
• • BMI percentile \> 85th for age and sex
• • Diagnosis of hepatic steatosis on imaging (ultrasound or MR).
• • Diagnosis of hepatic steatosis, NASH, or fibrosis on liver biopsy.
• • Elevated alanine aminotransferase (ALT) enzyme level.
• • Index of hepatic steatosis 8xALT/AST + BMI (+2 for girls) \> 30.
• Exclusion Criteria:
• • Known chronic systematic diseases
• • Any other serious conditions which, according to the doctor's judgment, would prevent compliance and safe participation in the study until completion.
• Exclusion criteria to be validated when contacting the participants and their parents/tutors:
• • Being pregnant.
• • Taking all kinds of prescription or over-the-counter natural health products/natural supplements/vitamins on an ongoing basis or within the next four months, excluding vitamin D.
• • Weight loss of 5% to 10% of the usual weight in the last six months before recruitment or weight change of 5% in the last three months.
• • Alcohol consumption \> two drinks/day or \> one day/week.
• • Known peanut allergy and/or to the medicinal ingredients contained in the active polyphenol supplement: elderberry, haskap, black chokeberry, blueberry, blackcurrant.
• • Any contraindications for MRI.