Hepatic Steatosis, Intimal Hyperplasia, Obesity, Childhood
Conditions
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
Detailed 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
Interventions
DIETARY_SUPPLEMENTEffect 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
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Through study completion an average of 1 year | Percentage of adverse events |
| Satisfaction of the participants and their point of view on the experience | Through study completion an average of 1 year | Percentage of satisfaction of participants enrolled |
| Recruitment | Through study completion an average of 1 year | Rate of recruitment |
| Retention: | Through study completion an average of 1 year | The percentage of adolescents who agree to participate in the study and the retention |
| Compliance with polyphenol supplementation | Through study completion an average of 1 year | Percentage of compliance |
| Effectiveness of the data collection procedure during the visits | Through study completion an average of 1 year | Percentage of completed visits |
| Sample size calculation for a randomized controlled study | Through study completion an average of 1 year | A sample size for a future randomized controlled study will be calculated from the estimates obtained during this pilot study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory marker 2 | At recruitment, after 60 days, and after 120 days | TNF alpha |
| Inflammatory marker 3 | At recruitment, after 60 days, and after 120 days | IL-6 |
| Lipid markers 1 | At recruitment, after 60 days, and after 120 days | Triglycerides |
| Lipid markers 2 | At recruitment, after 60 days, and after 120 days | LDL |
| Lipid markers 3 | At recruitment, after 60 days, and after 120 days | HDL |
| Change in hepatic steatosis MR | At recruitment, after 60 days, and after 120 days | mDixonQuant in percentage |
| Lipid markers 5 | At recruitment, after 60 days, and after 120 days | Apo B-100 |
| Lipid markers 6 | At recruitment, after 60 days, and after 120 days | Adiponectin, leptin |
| Liver function test | At recruitment, after 60 days, and after 120 days | ALT |
| Stool test | At recruitment, after 60 days, and after 120 days | Gut microbiome composition |
| Lipid markers 4 | At recruitment, after 60 days, and after 120 days | Apo AI |
| Change in hepatic steatosis B-mode US | At recruitment, after 60 days, and after 120 days | US liver echogenicity normal or increased |
| Change in intima media thickness (vascular compliance) | At recruitment, after 60 days, and after 120 days | Measurement of carotid artery intima media thickness in mm |
| Metabolic syndrome | At recruitment, after 60 days, and after 120 days | Insulin resistance evaluated by HOMA-IR mg\\dl |
| Cholesterol | At recruitment, after 60 days, and after 120 days | Triglyceride index (no unit) |
| Anthropometric measure | At recruitment, after 60 days, and after 120 days | Body mass index |
| Inflammatory marker 1 | At recruitment, after 60 days, and after 120 days | CRP |
Countries
Canada
Contacts
Primary ContactPrincipal investigator
Outcome results
None listed