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

April 30, 2012 updated by: Geok Lin Khor

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Childcare centres
        • Contact:
        • Principal Investigator:
          • Geok Lin Khor, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low GI group
Low Glycaemic index growing up milk
Other: Low Glycaemic index growing up milk
Low Glycaemic index growing up milk
Other: High GI group
Hi Glycaemic index growing up milk
Other: High GI growing up milk
High glycaemic index growing up milk

What is the study measuring?

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
Time Frame: 5 days
Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geok Lin Khor

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Acute01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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