Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04723849
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2021-01-14
Brief Title:
Efficacy Evaluation of a Mixed Compound of Antioxidants in Terms of Endothelium DamageFunction in Pediatric Subjects With Obesity
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Efficacy Evaluation of a Mixed Compound Magnesium Curcumin Resveratrol Quercetin Vitamin E Zinc Selenium Folic Acid Vitamin D in Terms of Endothelium DamageFunction in Pediatric Subjects With Obesity Double-blind Randomized Controlled Trial of 6-months Duration
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBELIX
Brief Summary:
The aim of our study was to test the effects on endothelium of a combination of curcumin resveratrol plus zinc magnesium selenium and Vitamin D in a cohort of pediatric subjects with obesity
Detailed Description:
The aim of our study was to test the effects on endothelium of a combination of curcumin resveratrol plus zinc magnesium selenium and Vitamin D in a cohort of pediatric subjects with obesity Endothelial function was assessed using two methodologies a post occlusive release hyperemic test PORH and a heat provocation test HPT Treatment tablet composition Auxilie Immuplus Envicon Medical Verona Italy Vitamin D3 2500 mcg Folic acid 9000 mcg Selenium 5500 mcg Magnesium 30000 mg Zinc 700 mg Curcum Meriva 10000 mg Polygonum dry extract 2041 mg of which Resveratrol 2000 mg Soy dry extract 3750 mg Placebo tablet composition Saccharose fructose aroma anti-agglomerate agents fatty acids magnesium salts silicium dioxide colorant riboflavin 5-sodium phosphate sweetener stevia glycoside sucralose neosperidin DC Both tablets treatment and placebo were similar in form color and flavor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None