Impact of polyphenol supplements on liver fat and blood vessel health in obese teens
The Effects of Polyphenol Supplementation on Hepatic Steatosis, Intima-media Thickness and Non-invasive Vascular Elastography in Obese Adolescents
This study is testing whether polyphenol supplements can help reduce liver fat and improve blood vessel health in obese teens.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT03994029 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of polyphenol supplementation on hepatic steatosis and vascular health in obese adolescents diagnosed with liver fat accumulation. It will assess the feasibility of a larger trial by examining recruitment, compliance, and participant satisfaction, while also comparing various imaging techniques for measuring liver fat. Additionally, the study will explore the impact of polyphenols on vascular health indicators such as intima-media thickness and vascular elastography. The findings could inform future research and treatment strategies for obesity-related liver conditions.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 with obesity and diagnosed hepatic steatosis.
Not a fit: Patients with chronic systemic diseases or those who have recently lost significant weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective dietary interventions for improving liver health and vascular function in obese adolescents.
How similar studies have performed: While the specific approach of using polyphenols in this context is novel, similar studies have shown promise in addressing obesity-related liver conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- CHU Sainte-Justine — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ramy El Jalbout, MD MSc — St. Justine's Hospital
- Study coordinator: Principal investigator
- Email: ramy.el-jalbout.hsj@ssss.gouv.qc.ca
- Phone: 5143454931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.