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

NCT ID: NCT01589003

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Mood Behaviour Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low GI group

Low Glycaemic index growing up milk

Group Type ACTIVE_COMPARATOR

Low Glycaemic index growing up milk

Intervention Type OTHER

Low Glycaemic index growing up milk

High GI group

Hi Glycaemic index growing up milk

Group Type OTHER

High GI growing up milk

Intervention Type OTHER

High glycaemic index growing up milk

Interventions

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Low Glycaemic index growing up milk

Low Glycaemic index growing up milk

Intervention Type OTHER

High GI growing up milk

High glycaemic index growing up milk

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Months

Maximum Eligible Age

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fonterra Research Centre

INDUSTRY

Sponsor Role collaborator

Geok Lin Khor

OTHER

Sponsor Role lead

Responsible Party

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Geok Lin Khor

Professor Khor Geok Lin

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Benton, Professor

Role: STUDY_CHAIR

Swansea University

Geok Lin Khor, Professor

Role: PRINCIPAL_INVESTIGATOR

International Medical University Malaysia

Peter Mitchell, Professor

Role: STUDY_CHAIR

University of Nottingham Malaysia Campus

Dr Shamsul Haque, PhD

Role: STUDY_CHAIR

Monash University Sunway Campus Malaysia

Snigdha Misra, PhD

Role: STUDY_CHAIR

International Medical University Malaysia

Locations

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Childcare centres

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Facility Contacts

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Geok Lin Khor, Professor

Role: primary

603-2731 7476

References

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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.

Reference Type DERIVED
PMID: 26174581 (View on PubMed)

Other Identifiers

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Acute01

Identifier Type: -

Identifier Source: org_study_id

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