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Status unknownNCT01589003Updated May 1, 2012

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

An interventional study of Low Glycaemic index growing up milk and High GI growing up milk in Mood Behaviour and Cognitive Function, sponsored by Geok Lin Khor. Status unknown at 1 site in Malaysia. Open to participants aged 15 Months to 21 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-01.

Sponsored by Geok Lin Khor · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
15 Months to 21 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mood Behaviour
  • Cognitive Function

Keywords

  • low GI milk mood behaviour cognitive function children
03

In context

Lead sponsor

This is the only study on the registry with Geok Lin Khor as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Months to 21 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Low GI group

    Low Glycaemic index growing up milk

    Other: Low Glycaemic index growing up milk

  • Other
    High GI group

    Hi Glycaemic index growing up milk

    Other: High GI growing up milk

Interventions

  • OtherLow Glycaemic index growing up milk

    Low Glycaemic index growing up milk

  • OtherHigh GI growing up milk

    High glycaemic index growing up milk

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 days

07

Study locations

1 of 1 sites recruiting
  • Childcare centres
    Kuala Lumpur, Malaysia
    • Geok Lin Khor, Professor · Contact · geoklin_khor@imu.edu.my · 603-2731 7476
    • Geok Lin Khor, Professor · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26174581 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01589003
Lead sponsor
Geok Lin Khor
Collaborators
Fonterra Research Centre
Responsible party
Geok Lin Khor (Professor Khor Geok Lin, International Medical University) — Sponsor-investigator
First posted
May 1, 2012
Start date
Apr 2012
Primary completion
Oct 2012 (estimated)
Completion
Feb 2013 (estimated)
Last update
May 1, 2012

Study contacts

David Benton, Professor
study chair · Swansea University
Geok Lin Khor, Professor
principal investigator · International Medical University Malaysia
Peter Mitchell, Professor
study chair · University of Nottingham Malaysia Campus
Dr Shamsul Haque, PhD
study chair · Monash University Sunway Campus Malaysia
Snigdha Misra, PhD
study chair · International Medical University Malaysia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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