An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children
研究概览
简要总结
The current study proposes to investigate the impact of a low glycaemic index (GI), fortified toddlers milkpowder on mood, behaviour and cognitive function in young children.
详细描述
The current study proposes to investigate the impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children. In choosing the tests it should be remembered that the investigators looking for short-term changes in functioning, such as the ability to sustain attention or improved mood. As such the investigators are not looking for measures of general cognitive functioning, stage of development or general behaviour but rather measures that are capable of monitoring changes from hour to hour or day to day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Months 至 21 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The sample will consist of only Malay children, an equal number of boys and girls, and whose parents have consent to the child participating in this trial.
排除标准
- •they will be excluded if underweight (BMI for age < 2 S.D.);
- •overweight (BMI for age > 2 S.D.;
- •have any chronic or serious illness or are currently not feeling well / taking medication;
- •have a history of allergy (particularly to milk), thyroid disease or diabetes mellitus.
- •Children currently part of an iron/zinc supplementation programme will be excluded as will any who are still being breast fed as there is no intention to discourage breastfeeding
结局指标
主要结局
The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children
时间窗: 5 days
Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire.
次要结局
未报告次要终点
研究者
Geok Lin Khor
Professor Khor Geok Lin
International Medical University