Effect of Polyphenol Supplementation on Hepatic Steatosis and Vascular Compliance
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 05/31/2019 |
| تم الإرسال لأول مرة: | 06/11/2019 |
| تم إرسال التسجيل المقدر: | 06/17/2019 |
| أول نشر: | 06/20/2019 |
| تم إرسال آخر تحديث: | 06/17/2019 |
| آخر تحديث تم نشره: | 06/20/2019 |
| تاريخ بدء الدراسة الفعلي: | 06/30/2019 |
| تاريخ الإنجاز الأساسي المقدر: | 03/31/2020 |
| التاريخ المتوقع لانتهاء الدراسة: | 03/31/2020 |
حالة أو مرض
التدخل / العلاج
Dietary Supplement: Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: Polyphenol supplementation 120mg per day of powder polyphenol for 60 days | |
| Placebo Comparator: Placebo 1 tab PO QD per day of placebo for 60 days |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 13 Years إلى 13 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | Inclusion Criteria: - Adolescents 13-< 18 - Residing in the Montreal area - BMI > 30Kg/m² (> 95th 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 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 |
النتيجة
مقاييس النتائج الأولية
1. Change in hepatic steatosis MR [At recruitment, after 60 days, and after 120 days]
2. Change in hepatic steatosis US Shear wave elastography [At recruitment, after 60 days, and after 120 days]
3. Change in hepatic steatosis B-mode US [At recruitment, after 60 days, and after 120 days]
مقاييس النتائج الثانوية
1. Change in intima media thickness [At recruitment, after 60 days, and after 120 days]
2. Change in vascular compliance [At recruitment, after 60 days, and after 120 days]
