Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 4:47 AM
Study NCT ID:
NCT01589003
Status:
UNKNOWN
Last Update Posted:
2012-05-01
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2012-04-30', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children', 'timeFrame': '5 days', 'description': 'Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low GI milk mood behaviour cognitive function children'], 'conditions': ['Mood Behaviour', 'Cognitive Function']}, 'referencesModule': {'references': [{'pmid': '26174581', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Months', 'minimumAge': '15 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* they will be excluded if underweight (BMI for age \\< 2 S.D.);\n* overweight (BMI for age \\> 2 S.D.;\n* have any chronic or serious illness or are currently not feeling well / taking medication;\n* have a history of allergy (particularly to milk), thyroid disease or diabetes mellitus.\n\nChildren 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'}, 'identificationModule': {'nctId': 'NCT01589003', 'briefTitle': 'The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants', 'organization': {'class': 'OTHER', 'fullName': 'IMU University, Malaysia'}, 'officialTitle': 'An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.', 'orgStudyIdInfo': {'id': 'Acute01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low GI group', 'description': 'Low Glycaemic index growing up milk', 'interventionNames': ['Other: Low Glycaemic index growing up milk']}, {'type': 'OTHER', 'label': 'High GI group', 'description': 'Hi Glycaemic index growing up milk', 'interventionNames': ['Other: High GI growing up milk']}], 'interventions': [{'name': 'Low Glycaemic index growing up milk', 'type': 'OTHER', 'description': 'Low Glycaemic index growing up milk', 'armGroupLabels': ['Low GI group']}, {'name': 'High GI growing up milk', 'type': 'OTHER', 'description': 'High glycaemic index growing up milk', 'armGroupLabels': ['High GI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Geok Lin Khor, Professor', 'role': 'CONTACT', 'email': 'geoklin_khor@imu.edu.my', 'phone': '603-2731 7476'}, {'name': 'Geok Lin Khor, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Childcare centres', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'David Benton, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Swansea University'}, {'name': 'Geok Lin Khor, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Medical University Malaysia'}, {'name': 'Peter Mitchell, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nottingham Malaysia Campus'}, {'name': 'Dr Shamsul Haque, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Monash University Sunway Campus Malaysia'}, {'name': 'Snigdha Misra, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'International Medical University Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geok Lin Khor', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonterra Research Centre', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Khor Geok Lin', 'investigatorFullName': 'Geok Lin Khor', 'investigatorAffiliation': 'IMU University, Malaysia'}}}}