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

Cognitive Function Clinical Trial

Official title:

An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589003
• Other study ID #: Acute01
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2012
• Last updated: April 30, 2012
• Start date: April 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2012
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Months to 21 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cognitive Function
• Mood Behaviour

Intervention

Other:
• Low Glycaemic index growing up milk
Low Glycaemic index growing up milk
• High GI growing up milk
High glycaemic index growing up milk

Locations

Country	Name	City	State
Malaysia	Childcare centres	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Geok Lin Khor	Fonterra Research Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No