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

This study is currently recruiting participants.
Verified April 2012 by International Medical University
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
History of Changes
  Purpose

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.


Condition Intervention
Mood Behaviour
Cognitive Function
 Other: Low Glycaemic index growing up milk
Other: High GI growing up milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.

Further study details as provided by International Medical University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: April 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low GI group
Low Glycaemic index growing up milk
 Other: Low Glycaemic index growing up milk
Low Glycaemic index growing up milk
High GI group
Hi Glycaemic index growing up milk
 Other: High GI growing up milk
High glycaemic index growing up milk

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

Ages Eligible for Study:   15 Months to 21 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589003

Locations
Malaysia
Childcare centres Recruiting
Kuala Lumpur, Malaysia
Contact: Geok Lin Khor, Professor     603-2731 7476     geoklin_khor@imu.edu.my    
Principal Investigator: Geok Lin Khor, Professor            
Sponsors and Collaborators
Geok Lin Khor
Fonterra Research Centre
Investigators
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
  More Information

No publications provided

Responsible Party: Geok Lin Khor, Professor Khor Geok Lin, International Medical University
ClinicalTrials.gov Identifier: NCT01589003     History of Changes
Other Study ID Numbers: Acute01
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: Malaysia: Ministry of Health

Keywords provided by International Medical University:
low GI milk mood behaviour cognitive function children

ClinicalTrials.gov processed this record on May 22, 2013