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

University of Verona

Status: Completed

Conditions: Childhood Obesity

Treatments: Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, Italy

Study type: Interventional

Funder types: Other

Identifiers

NCT04723849

5384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Tretment group

Experimental group

Description:

Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study.

Treatment:

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

Placebo group

Placebo Comparator group

Description:

Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study.

Treatment:

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