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
• Interventions: Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, Italy

• 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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-07-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

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

Arm && Interventions

Group	Intervention	Description
Tretment group	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.
Placebo group	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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