NCT01358149已完成不适用
Double Blind Controlled Trial of Cocoa-based Food in Children
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年5月1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
- 25
- 试验地点
- 1
- 主要终点
- Blood glucose concentration
研究概览
简要总结
Today, there is an important lack of knowledge on child metabolism and the effects of phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here, the investigators will monitor the metabolism of children using minimally invasive techniques at rest, and with physical/mental activities and assess the changes associated with the intake of cocoa-based food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must comply with all the following inclusion criteria:
- •Healthy and physically active, and no diabetes or metabolism related disorders in their first degree relatives (as determined by medical and activity questionnaire)
- •Caucasian, with English as a first language and an adequate standard of literacy.
- •BMI adjusted for age and gender which falls between the 9th and 91st as shown in the Child Growth Foundation BMI growth charts
- •8-13 years of age
- •Having obtained his/her informed assent
- •Having obtained his/her legal representative's informed consent
- •Willing to allow their family doctor (GP) to be informed about their participation in this study
排除标准
- •Subjects representing one or more of the following criteria are excluded from participation in the study.
- •Post-pubertal
- •Taking any medication
- •Undergoing medical treatment or investigations
- •Body mass index > 24
- •Suffer from chronic diseases (with regular intake of drugs, medical history)
- •Vegetarians
- •Vaccination in the last 4 months
- •Any know food allergies or intolerance
- •Pregnancy
- •Special diet or weight loss program (e.g. Atkins diet)
- •Acute illness
- •Fever, cold, flu
- •Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).
结局指标
主要结局
Blood glucose concentration
时间窗: Baseline will be fasting, and monitoring measures up to 7 hours after consumption
Time Frame: the effects of one-off consumption will be measured over a 7-8 hours period. Baseline will be fasting, and monitoring measures up to 7 hours after consumption. The subjects will be on controlled diet the day prior to the visit.
次要结局
- Metabolic monitoring(measured over a 7-8 hours period)
- mental monitoring(3.3 hours after intake)
- physical monitoring(two hours and four hours after concumption)
研究者
研究点 (1)
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