Childhood ObesityOBELIXNCT04723849
Efficacy Evaluation of a Mixed Compound of Antioxidants in Terms of Endothelium Damage/Function in Pediatric Subjects With Obesity.
A study testing Auxilie® Immuplus, Envicon Medical, Verona, Italy in people with Childhood Obesity, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Auxilie® Immuplus, Envicon Medical, Verona, Italy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of obesity as defined by a BMI higher than the 95 percentile for age based on the CDC standard
- Age 6-17 years
Who cannot join
- Children with genetic syndromes or cardiovascular diseases were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Auxilie® Immuplus, Envicon Medical, Verona, Italy
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxilie® Immuplus, Envicon Medical, Verona, ItalyDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Endothelial function was assessed using "heat provocation test" (HPT). Unit of measure: arbitrary perfusion units (PU)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Pietrobelli, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723849
- Sponsor's protocol ID
- 5384
- Acronym
- OBELIX
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04723849
- Acronym / sponsor ID
- OBELIX / 5384
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Tretment group | Experimental | Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, ItalySubjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. |
| Placebo group | Placebo comparator | Dietary Supplement: Auxilie® Immuplus, Envicon Medical, Verona, ItalySubjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of obesity as defined by a BMI higher than the 95 percentile for age based on the CDC standard
- Age 6-17 years
Key exclusion criteria (1 listed)
- Children with genetic syndromes or cardiovascular diseases were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auxilie® Immuplus, Envicon Medical, Verona, ItalySubjects 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). | Dietary supplement | Placebo group, Tretment group |
Primary outcome
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.
Time frame: 6 months
Endothelial function was assessed using a "post occlusive release hyperemic test". (PORH). Unit of measure: arbitrary perfusion units (PU)
1 secondary outcome
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.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auxilie® Immuplus, Envicon Medical, Verona, Italy in people with Childhood Obesity, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.