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临床试验/NCT04252105
NCT04252105已完成不适用

The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children

University of Ljubljana, Faculty of Medicine2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
2
主要终点
Oxidative stress biomarkers

研究概览

简要总结

Uncontrolled and prolonged oxidative stress plays an important role in the onset and progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given that many diseases can start as early as childhood, eating patterns in childhood and preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich foods can slow down the progression of chronic diseases.

In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and nutritional needs, so what is offered to them is very important. This study will evaluate the hypothesis that providing an antioxidant-rich diet in kindergartens can result in the reduction of biomarkers of oxidative stress.

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
None

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school

排除标准

  • • Children with chronic conditions (e.g. diabetes, asthma)
  • Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)

结局指标

主要结局

Oxidative stress biomarkers

时间窗: 2 weeks

Change in oxidative stress biomarkers of lipids (malondialdehyde (MDA), and four F2 - isoprostane isomers, namely 8 -iso-prostaglandin F2α (8-PGF2α), 11ß- prostaglandin F2α (11-PGF2α), 15 (R)-prostaglandin F2α (15-PGF 2α) and 8-iso, 15 prostaglandin F2α (8,15-PGF2α) ; proteins (o,o'-dityrosine (diY) and DNA 8-Hydroxy-2'-deoxyguanosine (8-OhdG) between day 1 and day 15 of the intervention diet, measured by HPLC-MS/MS

次要结局

未报告次要终点

研究者

发起方
University of Ljubljana, Faculty of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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