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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Childhood Obesity

Intervention / Treatment
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* Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, Italy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using a computer-generated randomization schedule, study supplement and placebo were randomized (1:1) into 70 batches (each consisting of 6 packs containing 30 tablets a pack) and each was given a unique identification number. The coordinator of the study maintained the randomization list. Study physicians, other study personnel, and parents or legal guardians were blinded to of the batches of medication and to the identification. Subjects who satisfied the inclusion for the study were assigned an identification number (linked to a batch) in sequential order. Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. A number of tablets not taken equal to of greater of 2 tablets/month was considered not adherence to the study (drop out).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tretment group<br>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<br>* 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).<br>|
| Placebo Comparator: Placebo group<br>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<br>* 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).<br>|

What is the study measuring?
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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 |