The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.

Conditions
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Mood Behaviour, Cognitive Function

Intervention / Treatment
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* Other: Low Glycaemic index growing up milk
* Other: High GI growing up milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 21 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low GI group<br>Low Glycaemic index growing up milk | Other: Low Glycaemic index growing up milk<br>* Low Glycaemic index growing up milk<br>|
| Other: High GI group<br>Hi Glycaemic index growing up milk | Other: High GI growing up milk<br>* High glycaemic index growing up milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children | Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low GI milk mood behaviour cognitive function children