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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of obesity as defined by a BMI higher than the 95 percentile for age based on the CDC standard
- •Age 6-17 years
排除标准
- •Children with genetic syndromes or cardiovascular diseases were excluded from the study
研究组 & 干预措施
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.
干预措施: Auxilie® Immuplus, Envicon Medical, Verona, Italy (Dietary Supplement)
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.
干预措施: Auxilie® Immuplus, Envicon Medical, Verona, Italy (Dietary Supplement)
结局指标
主要结局
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.
时间窗: 6 months
Endothelial function was assessed using a "post occlusive release hyperemic test". (PORH). Unit of measure: arbitrary perfusion units (PU)
次要结局
- 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)
研究者
Angelo Pietrobelli
Professor
Universita di Verona