Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
- Conditions
- Hepatic SteatosisIntimal HyperplasiaObesity, Childhood
- Interventions
- Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
- Registration Number
- NCT03994029
- Lead Sponsor
- St. Justine's Hospital
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polyphenol supplementation Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness 120mg per day of powder polyphenol for 60 days Placebo Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness 1 tab PO QD per day of placebo for 60 days
- Primary Outcome Measures
Name Time Method Recruitment Through study completion an average of 1 year Rate of recruitment
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
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
Adverse event Through study completion an average of 1 year Percentage of adverse events
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 Outcome Measures
Name Time Method Change in hepatic steatosis MR At recruitment, after 60 days, and after 120 days mDixonQuant in percentage
Stool test At recruitment, after 60 days, and after 120 days Gut microbiome composition
Change in hepatic steatosis B-mode US At recruitment, after 60 days, and after 120 days US liver echogenicity normal or increased
Inflammatory marker 2 At recruitment, after 60 days, and after 120 days TNF alpha
Lipid markers 1 At recruitment, after 60 days, and after 120 days Triglycerides
Lipid markers 3 At recruitment, after 60 days, and after 120 days HDL
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
Lipid markers 6 At recruitment, after 60 days, and after 120 days Adiponectin, leptin
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
Inflammatory marker 3 At recruitment, after 60 days, and after 120 days IL-6
Lipid markers 4 At recruitment, after 60 days, and after 120 days Apo AI
Liver function test At recruitment, after 60 days, and after 120 days ALT
Inflammatory marker 1 At recruitment, after 60 days, and after 120 days CRP
Lipid markers 2 At recruitment, after 60 days, and after 120 days LDL
Lipid markers 5 At recruitment, after 60 days, and after 120 days Apo B-100
Trial Locations
- Locations (1)
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada