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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
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
Effects of polyphenols IMT and vascular elastography. Anthropometric measurements, insulin resistance, inflammation, lipid/lipoprotein profile, gut microbiome and liver function
Evaluated different imaging modality for steatosis Different imaging modalities will be compared between children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyphenol supplementation | Experimental | 120mg per day of powder polyphenol for 60 days |
|
| Placebo | Placebo Comparator | 1 tab PO QD per day of placebo for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness | Dietary Supplement | Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Rate of recruitment | Through study completion an average of 1 year |
| Retention: | The percentage of adolescents who agree to participate in the study and the retention | Through study completion an average of 1 year |
| Compliance with polyphenol supplementation | Percentage of compliance | Through study completion an average of 1 year |
| Effectiveness of the data collection procedure during the visits | Percentage of completed visits | Through study completion an average of 1 year |
| Adverse event | Percentage of adverse events | Through study completion an average of 1 year |
| Satisfaction of the participants and their point of view on the experience | Percentage of satisfaction of participants enrolled | Through study completion an average of 1 year |
| Sample size calculation for a randomized controlled study | A sample size for a future randomized controlled study will be calculated from the estimates obtained during this pilot study. | Through study completion an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic steatosis MR | mDixonQuant in percentage | At recruitment, after 60 days, and after 120 days |
| Change in hepatic steatosis B-mode US | US liver echogenicity normal or increased |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria to be validated when contacting the participants and their parents/tutors:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | Contact | 5143454931 | ramy.el-jalbout.hsj@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ramy El Jalbout, MD MSc | St. Justine's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Recruiting | Montreal | Quebec | H3T1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38296273 | Derived | Moretti JB, Drouin A, Truong C, Youn E, Cloutier A, Alvarez F, Paganelli M, Grzywacz K, Jantchou P, Dubois J, Levy E, El Jalbout R. Effects of polyphenol supplementation on hepatic steatosis, intima-media thickness and non-invasive vascular elastography in obese adolescents: a pilot study protocol. BMJ Open. 2024 Jan 30;14(1):e074882. doi: 10.1136/bmjopen-2023-074882. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| At recruitment, after 60 days, and after 120 days |
| Change in intima media thickness (vascular compliance) | Measurement of carotid artery intima media thickness in mm | At recruitment, after 60 days, and after 120 days |
| Metabolic syndrome | Insulin resistance evaluated by HOMA-IR mg\dl | At recruitment, after 60 days, and after 120 days |
| Cholesterol | Triglyceride index (no unit) | At recruitment, after 60 days, and after 120 days |
| Anthropometric measure | Body mass index | At recruitment, after 60 days, and after 120 days |
| Inflammatory marker 1 | CRP | At recruitment, after 60 days, and after 120 days |
| Inflammatory marker 2 | TNF alpha | At recruitment, after 60 days, and after 120 days |
| Inflammatory marker 3 | IL-6 | At recruitment, after 60 days, and after 120 days |
| Lipid markers 1 | Triglycerides | At recruitment, after 60 days, and after 120 days |
| Lipid markers 2 | LDL | At recruitment, after 60 days, and after 120 days |
| Lipid markers 3 | HDL | At recruitment, after 60 days, and after 120 days |
| Lipid markers 4 | Apo AI | At recruitment, after 60 days, and after 120 days |
| Lipid markers 5 | Apo B-100 | At recruitment, after 60 days, and after 120 days |
| Lipid markers 6 | Adiponectin, leptin | At recruitment, after 60 days, and after 120 days |
| Liver function test | ALT | At recruitment, after 60 days, and after 120 days |
| Stool test | Gut microbiome composition | At recruitment, after 60 days, and after 120 days |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |