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NCT04723849 Clinical Trial

Efficacy Evaluation of a Mixed Compound of Antioxidants in Terms of Endothelium Damage/Function in Pediatric Subjects With Obesity.

Childhood Obesity Clinical Trial

— OBELIX  

Official title:
Efficacy Evaluation of a Mixed Compound (Magnesium, Curcumin, Resveratrol, Quercetin, Vitamin E, Zinc, Selenium, Folic Acid, Vitamin D) in Terms of Endothelium Damage/Function in Pediatric Subjects With Obesity: Double-blind, Randomized, Controlled Trial of 6-months Duration.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04723849
Other study ID # 5384
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date July 31, 2020

Study information
Verified date January 2021
Source Universita di Verona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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: 25,00 mcg, Folic acid: 90,00 mcg, Selenium: 55,00 mcg Magnesium: 300,00 mg, Zinc: 7,00 mg, Curcum (Meriva®): 100,00 mg Polygonum dry extract: 20,41 mg (of which Resveratrol: 20,00 mg), Soy dry extract: 37,50 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date July 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - Diagnosis of obesity as defined by a BMI higher than the 95 percentile for age based on the CDC standard - Age 6-17 years Exclusion Criteria: - Children with genetic syndromes or cardiovascular diseases were excluded from the study

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Auxilie® Immuplus, Envicon Medical, Verona, Italy
Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. Height (cm) and weight (kg) were measured for each child at every visit. Endothelial function was assessed using two methodologies: a "post occlusive release hyperemic test" (PORH) and a "heat provocation test" (HPT).

Locations
Country Name City State
Italy University of Verona Verona

Sponsors (1)
Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other To test the effects on endothelium and body composition of a combination of curcumin, resveratrol, plus zinc, magnesium, selenium and Vitamin D in a cohort of pediatric subjects with obesity. Height (cm), Weight (kg) used to calculate BMI (Kg/m2) 6 months
Primary 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 a "post occlusive release hyperemic test". (PORH). Unit of measure: arbitrary perfusion units (PU) 6 months
Secondary 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 "heat provocation test" (HPT). Unit of measure: arbitrary perfusion units (PU) 6 months
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