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

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.

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Dietary supplement: Auxilie® Immuplus, Envicon Medical, Verona, Italy

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy
    • University of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tretment group; Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study.	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).
Placebo Comparator: Placebo group; Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 5384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No