Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000417088
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
25/05/2010
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the cognitive effects of breakfast drinks in children after an exercise challenge
Scientific title
An evaluation of the cognitive effects of breakfast drinks in children after an exercise challenge
Secondary ID [1] 251828 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 257428 0
Mood 257429 0
Thirst/Satiety 257430 0
Condition category
Condition code
Diet and Nutrition 257574 257574 0 0
Other diet and nutrition disorders
Mental Health 257583 257583 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each treatment will consist of 150ml cold water (10°C) containing either
1. 11g carbohydrates and 6.5g milk (and 0.44g sucralose) 2. 11g sucrose and 6.5g milk
3. 6.5g milk (and 0.56g sucralose)
4. placebo 150ml water (and 0.56g sucralose).
(Sucralose is an artificial sweetener added to mask the difference in sweetness taste when compared to sucrose)

Participants come for 4 testing days, 1 week apart and are allowed 5 minutes to consume their allocated treatment for the day.

On each testing day, participants undergo their baseline cognitive and mood tests, followed by their treatment consumption. Then they have the exercise challenge (described below) and post-treatment cognitive and mood tests.

The exercise challenge consists of 4 tasks:
1) Badminton relay (timed) 6 minutes: Children run to the court (high intensity) and hit a birdie over the net at 1 of 3 different targets on the floor worth different amounts of points. They have to retrieve another birdie at the side of the court and aim at a target again. The children do this 3 times in total (moderate activity). After which they have to run to the front of the line and start the next person in their team (high intensity) whilst they rest and cheer (low). The score is the maximum number of points obtained per team.

2) Potato and spoon relay race (timed) 6 minutes: Children run through a course with a potato on a spoon and place the potato in a bucket and then race back to their team where the next team mate is waiting to take over. Repeat back and forth for a total of six minutes. The score for each team is the number of lengths covered minus a penalty point for dropping the potato.

3) Football relay (timed) 6 minutes: Children dribble a ball through a course and shoot at a target, and after run to the beginning of the line to start the next person on their team, after which they watch and cheer their team mates. This is repeated back and forth for a total of 6 minutes. The two teams of three children compete against each other. The score is the total targets hit per team in the 6 minutes.

4) Sack race relay (timed) 6 minutes: Children (1 per team) get into a sack and hop to a predetermined target and back. Once they have returned to the front of the line, they exchange the sack with the next child in line who then hops to the target and back while the other children encourage. This is repeated for a "race" of 90 seconds followed by 30 seconds of rest between races. A total of three 90-second races will be performed for a total of 6 minutes. The score is the number of lengths covered in each race and over the total 6 minutes.
Intervention code [1] 256529 0
Lifestyle
Comparator / control treatment
Placebo (containing water)
Control group
Placebo

Outcomes
Primary outcome [1] 258495 0
Arrow Flankers: Participants have to respond to a symbol in the presence of distractors. Primary outcome is the number of correct responses.
Timepoint [1] 258495 0
Baseline, immediately after exercise task
Secondary outcome [1] 264290 0
Cognitive Tasks - Serial Subtractions, Cognitive Drug Research (CDR) Battery, digit symbol coding, speed of information processing tasks
Timepoint [1] 264290 0
Baseline, immediately after exercise task

Eligibility
Key inclusion criteria
All subjects must comply with all the following inclusion criteria:
10-12 years of age with no birthday during the study period (which will make them aged 13 during the study)
Healthy (i.e. absence of exclusion criteria)
Normal static binocular acuity (corrected or uncorrected)
Body Mass index normal for this age group in Malaysia
Having obtained his/ her or his/her legal representative’s informed consent
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects representing one or more of the following criteria are excluded from participation in the study.
A history of diabetes, glucose intolerance or any other metabolic disorder
Any current or history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, hematological or psychiatric illness
Use of prescription medication, illicit, herbal or recreational drugs, including alcohol and tobacco
The previous use of dietary mineral and/or vitamin supplements within the last month.
Any sensory or motor deficits that could reasonably be expected to affect test performance
No allergy or hypersensitivity to any ingredients in the investigational products
Subjects who cannot be expected to comply with treatment
Currently participating or having participated in another clinical trial during the 2 months immediately prior to the beginning of this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The parents of the participants are first screened over the phone to ensure their child is eligible to participate and the parent is willing to take their child to all the visits. They first come in for a practice day where the participant does a practice version of all the cognitive tests to become familiar with study day procedures. Once they complete all the practice day measures, they will be allocated a numerical identifying number and be randomly allocated to a treatment sequence where they receive a different treatment on each day they come in.
The person who determined if a participant was eligible for inclusion in this trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation concealment was done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 2649 0
Malaysia
State/province [1] 2649 0
Kuching, Sarawak

Funding & Sponsors
Funding source category [1] 257014 0
Commercial sector/Industry
Name [1] 257014 0
Nestec
Country [1] 257014 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Nestec
Address
PO Box 44, CH-1000 Lausanne 26
Country
Switzerland
Secondary sponsor category [1] 256273 0
None
Name [1] 256273 0
Address [1] 256273 0
Country [1] 256273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259033 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 259033 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 259033 0
Australia
Date submitted for ethics approval [1] 259033 0
Approval date [1] 259033 0
05/03/2010
Ethics approval number [1] 259033 0
2009.259

Summary
Brief summary
Visit 1 – Practice day
The first visit is a training session. The study will be explained to you and your child in detail and you may ask the researchers any questions or raise any concerns that you may have about the study. During the training session you will be asked to complete a demographic and medical questionnaire for your child and provide informed consent for your child to participate in the study. Your child will then complete the cognitive tests that they will be doing during their subsequent testing sessions. The purpose of this visit is to familiarize your child with the tasks and study procedures. They will also be given a habitual diet questionnaire to fill in and a 24 hour food diary to fill in the day before the study session.

Visits 2-5 – Testing days
Following the practice day, your child will be instructed to refrain from consuming anything other than water from 22.00 on the night before the study days and to arrive at the test site in a rested state. On study days, they will be given a standard breakfast between 07:00 and 07:30. They will first complete some questionnaires on their current mood and some computerised cognitive tests between 09.30 and 10.00. Your child will be given one of the 4 drinks to consume at 10:00 and will be required to consume the drink within 5 minutes. Neither you, your child nor the researcher will know which drink they will have on each test day. Between 10:30 and 11:00 your child will take part in different sport activities that include a badminton game, running with a potato and spoon, jumping in a sack and a football game. They will participate in these sport tasks in a team of three children and will compete against another team of three children. Following this, they will complete the same mood questionnaires and computerised cognitive tests. Before leaving your child will be informed whether they were on the winning team in the sports tasks of the study. They will complete this testing day 4 times (1 week apart) and receive a different drink each testing day. This study will not interfere with normal school activities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31200 0
Address 31200 0
Country 31200 0
Phone 31200 0
Fax 31200 0
Email 31200 0
Contact person for public queries
Name 14447 0
Con Stough
Address 14447 0
400 Burwood Rd
Hawthorn VIC 3122
Country 14447 0
Australia
Phone 14447 0
+613 9214 8167
Fax 14447 0
Email 14447 0
[email protected]
Contact person for scientific queries
Name 5375 0
Con Stough
Address 5375 0
400 Burwood Rd
Hawthorn VIC 3122
Country 5375 0
Australia
Phone 5375 0
+613 9214 8167
Fax 5375 0
Email 5375 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.