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

Universita di Verona48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Childhood Obesity

Interventions

Auxilie® Immuplus, Envicon Medical, Verona, ItalyDIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Verona

Verona, Italy

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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