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

Not Applicable
Completed
Conditions
Childhood Obesity
Registration Number
NCT04723849
Lead Sponsor
Universita di Verona
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: 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.6 months

Endothelial function was assessed using a "post occlusive release hyperemic test". (PORH). Unit of measure: arbitrary perfusion units (PU)

Secondary Outcome Measures
NameTimeMethod
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.6 months

Endothelial function was assessed using "heat provocation test" (HPT). Unit of measure: arbitrary perfusion units (PU)

Trial Locations

Locations (1)

University of Verona

🇮🇹

Verona, Italy

University of Verona
🇮🇹Verona, Italy

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