免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
Study Description
Brief Summary:
The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic elastography and magnetic resonance hepatic spectroscopy in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity, Childhood Hepatic Steatosis Intimal Hyperplasia | Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness | Not Applicable |
Detailed Description:
Obesity leads to hepatic steatosis. Early changes in vascular compliance due to obesity have been shown to be reversible. Many studies have shown a positive effect of polyphenols (natural product in apples and grapes) on the liver fat burden. Three visits will be planified.
Visit 1: Demographic data and liver and vascular imaging. Blood and stool tests.
Randomization to polyphenol versus placebo. Visit 2 at 60 days. Demographic data and liver and vascular imaging. Blood tests. Stop the intervention.
Visit 3 at 120 days. Demographic data and liver and vascular imaging. Blood and stool tests.
This study will determine the feasibility of a randomized controlled trial evaluating the effect of polyphenols on hepatic steatosis and the vascular subclinical radiologic changes related to obesity.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Polyphenol Supplementation on Hepatic Steatosis, Non-invasive Vascular Elastography and Intima Media Thickness in Obese Adolescents |
| Actual Study Start Date : | June 4, 2021 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | September 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Polyphenol supplementation
120mg per day of powder polyphenol for 60 days
|
Dietary Supplement: 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
|
|
Placebo Comparator: Placebo
1 tab PO QD per day of placebo for 60 days
|
Dietary Supplement: 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
|
Outcome Measures
Primary Outcome Measures :
- Change in hepatic steatosis MR [ Time Frame: At recruitment, after 60 days, and after 120 days ]MR spectroscopy
- Change in hepatic steatosis US Shear wave elastography [ Time Frame: At recruitment, after 60 days, and after 120 days ]US elastography
- Change in hepatic steatosis B-mode US [ Time Frame: At recruitment, after 60 days, and after 120 days ]Conventional US
Secondary Outcome Measures :
- Change in intima media thickness [ Time Frame: At recruitment, after 60 days, and after 120 days ]Measurement of carotid artery intima media thickness
- Change in vascular compliance [ Time Frame: At recruitment, after 60 days, and after 120 days ]Non invasive vascular elastography
Eligibility Criteria
| Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adolescents 12-< 18
- Residing in the Montreal area
- BMI > 20-24Kg/m² (> 85th percentile for age and sex)
- Hepatic MRI spectroscopy showing ratio > 5.5% lipid/water
- Not being pregnant (if sexually active, using an effective contraceptive method)
Exclusion Criteria:
- chronic disease, including diabetes, hypercholesterolemia, hypertension, hepatitis (viral and autoimmune), Wilson's disease and Alpha 1 antitrypsin.
- Taking medications or supplements
- Having a significant weight loss in the last 6 months prior to recruitment
- Alcohol consumption > 2 drinks per day or consume more than 1 day per week
- Known peanut allergies
- Contraindications for MRI
Contacts and Locations
Contacts
| Contact: Principal investigator | 5143454931 | ramy.el-jalbout.hsj@ssss.gouv.qc.ca |
Locations
| Canada, Quebec | |
| CHU Sainte-Justine | Recruiting |
| Montreal, Quebec, Canada, H3T1C5 | |
| Contact: Ramy El Jalbout, MD ramy.jalbout@gmail.com | |
| Contact: Anik Cloutier, MSc anik.cloutier2.hsj@ssss.gouv.qc.ca | |
Sponsors and Collaborators
St. Justine's Hospital
Investigators
| Principal Investigator: | Ramy El Jalbout, MD MSc | St. Justine's Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 12, 2019 | ||||
| First Posted Date ICMJE | June 21, 2019 | ||||
| Last Update Posted Date | June 8, 2021 | ||||
| Actual Study Start Date ICMJE | June 4, 2021 | ||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance | ||||
| Official Title ICMJE | Effect of Polyphenol Supplementation on Hepatic Steatosis, Non-invasive Vascular Elastography and Intima Media Thickness in Obese Adolescents | ||||
| Brief Summary | The main objective is to study the effect of polyphenol supplementation on hepatic steatosis as measured by hepatic ultrasound, hepatic elastography and magnetic resonance hepatic spectroscopy in obese adolescents known for hepatic steatosis as diagnosed by liver biopsy | ||||
| Detailed Description |
Obesity leads to hepatic steatosis. Early changes in vascular compliance due to obesity have been shown to be reversible. Many studies have shown a positive effect of polyphenols (natural product in apples and grapes) on the liver fat burden. Three visits will be planified. Visit 1: Demographic data and liver and vascular imaging. Blood and stool tests. Randomization to polyphenol versus placebo. Visit 2 at 60 days. Demographic data and liver and vascular imaging. Blood tests. Stop the intervention. Visit 3 at 120 days. Demographic data and liver and vascular imaging. Blood and stool tests. This study will determine the feasibility of a randomized controlled trial evaluating the effect of polyphenols on hepatic steatosis and the vascular subclinical radiologic changes related to obesity. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Dietary Supplement: 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
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
60 | ||||
| Original Estimated Enrollment ICMJE |
20 | ||||
| Estimated Study Completion Date ICMJE | September 2022 | ||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 12 Years to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03994029 | ||||
| Other Study ID Numbers ICMJE | 2019-2278 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Ramy El Jalbout, St. Justine's Hospital | ||||
| Study Sponsor ICMJE | St. Justine's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | St. Justine's Hospital | ||||
| Verification Date | June 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
