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

NCT01589003 | Unknown DMC

• 1 other identifier: Acute01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood Behaviour; Cognitive Function

Keywords

low GI milk mood behaviour cognitive function children

Outcome Measures

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.

  5 days

Study Arms (2)

Low GI group

ACTIVE COMPARATOR

Low Glycaemic index growing up milk

Other: Low Glycaemic index growing up milk

High GI group

OTHER

Hi Glycaemic index growing up milk

Other: High GI growing up milk

Interventions

Low Glycaemic index growing up milk OTHER

Low Glycaemic index growing up milk

Low GI group

High GI growing up milk OTHER

High glycaemic index growing up milk

High GI group

Eligibility Criteria

• Age: 15 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Geok Lin Khor: lead
• Fonterra Research Centre: collaborator

Study Sites (1)

Childcare centres

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 26174581 DERIVED

Study Officials

• David Benton, Professor

  Swansea University

  STUDY CHAIR

• Geok Lin Khor, Professor

  International Medical University Malaysia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Khor Geok Lin

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

MY (1)