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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by International Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fonterra Research Centre
Information provided by (Responsible Party):
Geok Lin Khor, International Medical University
ClinicalTrials.gov Identifier:
NCT01589003
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012

April 27, 2012
April 30, 2012
April 2012
October 2012   (final data collection date for primary outcome measure)
The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire.
Same as current
Complete list of historical versions of study NCT01589003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants
An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Mood Behaviour
  • Cognitive Function
  • Other: Low Glycaemic index growing up milk
    Low Glycaemic index growing up milk
  • Other: High GI growing up milk
    High glycaemic index growing up milk
  • Active Comparator: Low GI group
    Low Glycaemic index growing up milk
    Intervention: Other: Low Glycaemic index growing up milk
  • High GI group
    Hi Glycaemic index growing up milk
    Intervention: Other: High GI growing up milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
February 2013
October 2012   (final data collection date for primary outcome measure)

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

Both
15 Months to 21 Months
Yes
Not Provided
Malaysia
 
NCT01589003
Acute01
Yes
Geok Lin Khor, International Medical University
Geok Lin Khor
Fonterra Research Centre
Study Chair: David Benton, Professor Swansea University
Principal Investigator: Geok Lin Khor, Professor International Medical University Malaysia
Study Chair: Peter Mitchell, Professor University of Nottingham Malaysia Campus
Study Chair: Dr Shamsul Haque, PhD Monash University Sunway Campus Malaysia
Study Chair: Snigdha Misra, PhD International Medical University Malaysia
International Medical University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP