The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants
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| First Received Date ICMJE | April 27, 2012 | ||||||||||||||||||||
| Last Updated Date | April 30, 2012 | ||||||||||||||||||||
| Start Date ICMJE | April 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children [ Time Frame: 5 days ] [ Designated as safety issue: No ] Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01589003 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants | ||||||||||||||||||||
| Official Title ICMJE | An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants. | ||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||||||||||||||
| Estimated Completion Date | February 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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 |
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| Gender | Both | ||||||||||||||||||||
| Ages | 15 Months to 21 Months | ||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
| Contacts ICMJE | Not Provided | ||||||||||||||||||||
| Location Countries ICMJE | Malaysia | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01589003 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | Acute01 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | Geok Lin Khor, International Medical University | ||||||||||||||||||||
| Study Sponsor ICMJE | Geok Lin Khor | ||||||||||||||||||||
| Collaborators ICMJE | Fonterra Research Centre | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | International Medical University | ||||||||||||||||||||
| Verification Date | April 2012 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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