Mood BehaviourNCT01589003
The Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants
A study testing Low Glycaemic index growing up milk and High GI growing up milk in people with Mood Behaviour and Cognitive Function, run by Geok Lin Khor at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 15 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Mood Behaviour, Cognitive Function
- What is being tested?
- Low Glycaemic index growing up milk and High GI growing up milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Childcare centres
Kuala Lumpur
Geok Lin Khor, Professor, 603-2731 7476, geoklin_khor@imu.edu.my
Geok Lin Khor, Professor
About this study
Official title: An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.
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.
Read the 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.
- Conditions
- Mood Behaviour, Cognitive Function
- Being tested
- Low Glycaemic index growing up milk, High GI growing up milk
- Keywords
- low GI milk mood behaviour cognitive function children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycaemic index growing up milkOther
Low Glycaemic index growing up milk
High GI growing up milkOther
High glycaemic index growing up milk
| Study group | Role | What they receive |
|---|---|---|
| Low GI group | Active comparator | Low Glycaemic index growing up milk Receives: Other: Low Glycaemic index growing up milk |
| High GI group | Other | Hi Glycaemic index growing up milk Receives: Other: High GI growing up milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geok Lin Khor
- Sponsor type
- University, hospital or other
- Collaborators
- Fonterra Research Centre
- Responsible party
- Sponsor-investigator, Geok Lin Khor, IMU University, Malaysia
- Investigators
- David Benton, Professor, Study chair, Swansea UniversityGeok Lin Khor, Professor, Principal investigator, International Medical University MalaysiaPeter Mitchell, Professor, Study chair, University of Nottingham Malaysia CampusDr Shamsul Haque, PhD, Study chair, Monash University Sunway Campus MalaysiaSnigdha Misra, PhD, Study chair, International Medical University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589003
- Sponsor's protocol ID
- Acute01
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26174581
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study to Consider the Impact of Milk-products Differing in Their Glycaemic Properties on the Behaviour of Infants.
- ClinicalTrials.gov ID
- NCT01589003
- Acronym / sponsor ID
- Acute01
- Conditions
- Mood Behaviour, Cognitive Function
- Keywords
- low GI milk mood behaviour cognitive function children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Geok Lin KhorUniversity, hospital or other
- Collaborators
- Fonterra Research Centre
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low GI group | Active comparator | Other: Low Glycaemic index growing up milkLow Glycaemic index growing up milk |
| High GI group | Other | Other: High GI growing up milkHi Glycaemic index growing up milk |
Who may qualify
- Ages
- 15 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glycaemic index growing up milkLow Glycaemic index growing up milk | Other | Low GI group |
| High GI growing up milkHigh glycaemic index growing up milk | Other | High GI group |
Primary outcome
The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children
Time frame: 5 days
Evaluated by Parental ratings, Tempertment mood questionnaires, Ethological description of free play, Distractability task, actiwatch, Sleep Questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Derived from this study: PubMed 26174581Misra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Benton, Professor study chair
Swansea University
Geok Lin Khor, Professor principal investigator
International Medical University Malaysia
Peter Mitchell, Professor study chair
University of Nottingham Malaysia Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycaemic index growing up milk and High GI growing up milk in people with Mood Behaviour and Cognitive Function, run by Geok Lin Khor at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of a low GI, fortified toddlers milkpowder on mood, behaviour and cognitive function in young children (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.