None listed
Conditions
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.
Interventions
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 d
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.
Sponsors
Nestec
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
10 Years to 12 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed