Recruiting

Polyphenol Supplementation

Sponsor:

St. Justine's Hospital

Code:

NCT03994029

Conditions

Obesity, Childhood

Hepatic Steatosis

Intimal Hyperplasia

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Conditions

Obesity, Childhood

Hepatic Steatosis

Intimal Hyperplasia

Study ID

NCT03994029

Start date

Jul 4, 2021

Status verified date

Jan, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Polyphenol supplementation

120mg per day of powder polyphenol for 60 days

placebo comparator: Placebo

1 tab PO QD per day of placebo for 60 days

Interventions

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

Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness

Primary outcome measure

  • Recruitment [ Time Frame: Through study completion an average of 1 year ]
  • Retention: [ Time Frame: Through study completion an average of 1 year ]
  • Compliance with polyphenol supplementation [ Time Frame: Through study completion an average of 1 year ]
  • Effectiveness of the data collection procedure during the visits [ Time Frame: Through study completion an average of 1 year ]
  • Adverse event [ Time Frame: Through study completion an average of 1 year ]
  • Satisfaction of the participants and their point of view on the experience [ Time Frame: Through study completion an average of 1 year ]
  • Sample size calculation for a randomized controlled study [ Time Frame: Through study completion an average of 1 year ]

Central Contacts and Locations

Central contacts

Principal investigator

5143454931ramy.el-jalbout.hsj@ssss.gouv.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Ramy El Jalbout, MD

ramy.jalbout@gmail.com

Anik Cloutier, MSc

anik.cloutier2.hsj@ssss.gouv.qc.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Jan 23, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2024-01-23.