Clinical trial NCT01589003: The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants
Official title: An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood Behaviour
Cognitive Function
Keywords: low GI milk mood behaviour cognitive function children
Lead sponsor: International Medical University
Sponsor class: OTHER
Collaborators: name: Fonterra Research Centre
First posted: 2012-05-01
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Childcare centres
Study officials:
affiliation: Swansea University
name: David Benton, Professor
role: STUDY_CHAIR
affiliation: International Medical University Malaysia
name: Geok Lin Khor, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham Malaysia Campus
name: Peter Mitchell, Professor
role: STUDY_CHAIR
affiliation: Monash University Sunway Campus Malaysia
name: Dr Shamsul Haque, PhD
role: STUDY_CHAIR
affiliation: International Medical University Malaysia
name: Snigdha Misra, PhD
role: STUDY_CHAIR
References:
citation: Misra S, Khor GL, Mitchell P, Haque S, Benton D. A pilot study to determine the short-term effects of milk with differing glycaemic properties on sleep among toddlers: a randomised controlled trial. BMC Pediatr. 2015 Jul 15;15:79. doi: 10.1186/s12887-015-0393-9.