Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance

Last updated: January 22, 2024
Sponsor: St. Justine's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Hepatic Fibrosis

Treatment

Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness

Clinical Study ID

NCT03994029
2019-2278
  • Ages 12-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Known chronic systematic diseases
  • Any other serious conditions which, according to the doctor's judgment, would preventcompliance and safe participation in the study until completion. Exclusion criteria to be validated when contacting the participants and theirparents/tutors:
  • Being pregnant.
  • Taking all kinds of prescription or over-the-counter natural health products/naturalsupplements/vitamins on an ongoing basis or within the next four months, excludingvitamin D.
  • Weight loss of 5% to 10% of the usual weight in the last six months before recruitmentor 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 activepolyphenol supplement: elderberry, haskap, black chokeberry, blueberry, blackcurrant.
  • Any contraindications for MRI.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
Phase:
Study Start date:
July 04, 2021
Estimated Completion Date:
December 31, 2024

Study Description

  1. Evaluate the feasibility of a larger, open-label, randomized, controlled trial on the effects of polyphenol supplementation:

    Recruitment, compliance to polyphenol supplementation and the visit roadmaps Duration of the radiological exams and participants' satisfaction and point of view on the experience. Test the relevance of using a food diary. Test the effectiveness of the data collection procedure during the visits. Explore the obstacles encountered while performing the radiological exams and the rate of adverse events (AE). Calculate the sample size of the future randomized clinical study

  2. Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function

  3. Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children

Connect with a study center

  • CHU Sainte-Justine

    Montreal, Quebec H3T1C5
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.