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

NCT04723849 | Completed

• 1 other identifier: 5384
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 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.

  6 months

Study Arms (2)

Tretment group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Auxilie® Immuplus, Envicon Medical, Verona, Italy DIETARY_SUPPLEMENT

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 group; Tretment group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of obesity as defined by a BMI higher than the 95 percentile for age based on the CDC standard
• Age 6-17 years

You may not qualify if:

• Children with genetic syndromes or cardiovascular diseases were excluded from the study

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, Italy

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 26, 2021
• Study Start: February 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

IT (1)