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Trial registered on ANZCTR


Registration number
ACTRN12618000887279
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
25/05/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study to determine whether Australian children aged 8-13 years will eat almonds for 8 weeks and the impact on cognitive perfomance.
Scientific title
A feasibility study to determine whether Australian children aged 8-13 years will eat almonds for 8 weeks and the impact on cognitive perfomance.
Secondary ID [1] 294781 0
none
Universal Trial Number (UTN)
Trial acronym
Snack Patterns using Almonds and wateR and the effects on Cognition in Kids -SPARC-K
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Performance 307712 0
Sleep hygiene 307713 0
Condition category
Condition code
Diet and Nutrition 306761 306761 0 0
Other diet and nutrition disorders
Mental Health 306767 306767 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an 18-week randomized, controlled cross-over feasibility study. During the intervention phase (8 weeks) participants will consume 30g of almonds, 5 days a week. There will be a control phase (8 weeks) with participants consuming 250ml bottled water, 5 days a week. A washout period of 2 weeks will occur between phases.
Following a washout period of 2 weeks, children will then cross-over to the alternate condition for another 8 weeks.

Participants will consume 30g of raw, unsalted almonds for 5 days a week. Participants will be provided with individual packets of almonds. Test foods can be eaten at any time of the day as decided by the participant, and they may choose to consume them all in one sitting or throughout the day. Participants will be asked to complete a checklist to record consumption of test foods as well as to keep empty packaging to determine compliance. In the almond phase participants will be asked not to consume nuts or nut products other than the almonds provided.
Intervention code [1] 301088 0
Lifestyle
Comparator / control treatment
In the control phase participants will be given 250ml bottled water as an attention control, to be consumed 5 days per week for 8 weeks. The bottled water may be consumed at any time throughout the day and will be in addition to their usual water consumption. Participants will be asked to complete a checklist to record consumption of test foods as well as to keep empty packaging to determine compliance.
During the control phase participants will be asked not to consume nuts or nut products.
Control group
Active

Outcomes
Primary outcome [1] 305759 0
Examine the feasibility of investigating whether Australian Children aged 8-13 years will consume 30g of almonds on 5 days per week for 8 weeks.
The primary outcome measure will be compliance to each dietary intervention, to determine feasibility.
Compliance will be determined by checklists and counts of empty packaging of consumed test foods.
Timepoint [1] 305759 0
After completion of 8 weeks of dietary intervention
Secondary outcome [1] 346387 0
Cognitive function scores as determined by validated COMPASS (computerised mental performance assessment) tests of attention and memory.
Outcome measures will include scores for attention/concentration, executive function, working memory, secondary memory, spatial memory.
Timepoint [1] 346387 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [2] 346388 0
Effect of sleep quality and quantity on cognitive performance in primary school aged children, as determined by the Karolinska sleepiness scale.
This is a composite outcome measure
Timepoint [2] 346388 0
Data will be collected for 1 week prior to the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [3] 346394 0
Body Mass Index as determined by weight divided by height squared.
Weight will be measured by electronic scales. Height will be determined by wall mounted statiometer.
Timepoint [3] 346394 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [4] 346395 0
Assessment of dietary profile as determined by the Australian Child and Adolescent Eating Survey.
Timepoint [4] 346395 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [5] 346396 0
Assessment of physical activity levels as determined by the validated Physical Activity Questionniare for Children (cPAQ).
Timepoint [5] 346396 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [6] 346397 0
Acute liking scores for test foods, as determined by validated Labelled Affect Magnitude Scales (LAMS)
Timepoint [6] 346397 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [7] 347298 0
Effect of sleep quality and quantity on cognitive performance in primary school aged children as determined by the Pediatric Sleep Problem Survey questionnaire.
This is a composite outcome measure.
Timepoint [7] 347298 0
At the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [8] 347299 0
Effect of sleep quality and quantity on cognitive performance in primary school aged children as determined by a 7-day recording of sleep and activity patterns by activity monitor-Actiwatch.
This is a composite outcome measure.
Timepoint [8] 347299 0
Data will be collected for 1 week prior to the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.
Secondary outcome [9] 347309 0
Acute liking scores for test foods, as determined by validated Food Action Rating Scale.
Timepoint [9] 347309 0
Data will be collected for 1 week prior to the start and end of each 8 week intervention.
As the interventions will be separated by a 2 week washout, the outcome will be measured at baseline (week 0), week 8, week 10 and week 18.

Eligibility
Key inclusion criteria
-Males and females aged 8-13 years
-No allergies to tree nuts, peanuts
-No food allergies/intolerances that would exclude them from eating the snack prior to cognitive testing
Minimum age
8 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Are unable to understand and/or perform required computerised cognitive tests according to practice test results.
-Have a diagnosed sleep or behavioural disorder, e.g. sleep apnoea, ADHD
-Take vitamin, mineral, herbal supplementation or medications that may have an impact on study outcomes.
-Failure to satisfy the investigator regarding suitability to participate for any other reason.

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)
As this is a cross over trial, all participants will undertake both intervention phases, the order will be determined by central randomisation by computer using a random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur by computerised random number generator. As this is a cross over trial, all participants will undertake both intervention phases, the order will be determined randomly.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Baseline characteristics between the groups (almond followed by water compared with water followed by almonds) will be compared using an unpaired t-test. Within participant change will be compared between phases using paired t-tests. Statistical significance will be set at P<0·05.

We have proposed a sample size of 40 children, which is acceptable for pilot and feasibility studies noting that we expect that some children will drop out over the intervention (in adults we typically see ~ 20% drop out). The primary outcome measure for this feasibility trial is compliance to consuming the test foods over the 8 weeks. Using a cross-over study design means each child is their own control and we will calculate changes for each between the two phases.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 299388 0
Commercial sector/Industry
Name [1] 299388 0
The Almond Board of Australia
Address [1] 299388 0
1801 Bookpurnong Rd
Loxton SA 5333
Country [1] 299388 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 298667 0
Individual
Name [1] 298667 0
Assoc.Prof Alison Coates
Address [1] 298667 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country [1] 298667 0
Australia
Secondary sponsor category [2] 298673 0
Individual
Name [2] 298673 0
Prof. Jon Buckley
Address [2] 298673 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country [2] 298673 0
Australia
Secondary sponsor category [3] 298674 0
Individual
Name [3] 298674 0
Dr Alison Hill
Address [3] 298674 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country [3] 298674 0
Australia
Secondary sponsor category [4] 298675 0
Individual
Name [4] 298675 0
Dr Ashleigh Smith
Address [4] 298675 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country [4] 298675 0
Australia
Secondary sponsor category [5] 298676 0
Individual
Name [5] 298676 0
Prof. Andrew Scholey
Address [5] 298676 0
Centre for Human Psychopharmacology
Swinburne University, Hawthorn Campus,
John St, Hawthorn, VIC 3122
Country [5] 298676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300291 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 300291 0
Research and Innovation Services
Mawson Lakes Campus
University of South Australia
PO Box 2471
Adelaide, SA, 5001
Ethics committee country [1] 300291 0
Australia
Date submitted for ethics approval [1] 300291 0
26/02/2018
Approval date [1] 300291 0
26/03/2018
Ethics approval number [1] 300291 0
201047

Summary
Brief summary
The primary aim of this study is to examine the feasibility of investigating whether Australian children aged 8-13 years will consume 30g almonds on 5 days per week for 8 weeks. The secondary aim is to compare the effects of consuming almonds on cognitive function compared to a nut-free control phase. Additionally, this study aims to examine the effect of sleep quality and quantity on cognitive performance in primary school aged children.
This study is an 18-week randomized, controlled cross-over feasibility study. Forty free-living healthy children aged 8-13 years (without known nut allergies) will be randomized (using a random number generator) to start in either the almond or the control phase for 8 weeks. Following a washout period for 2 weeks, children will then cross-over to the alternate condition for another 8 weeks. Children will undergo cognitive performance testing using computerized tasks five times - screening (for familiarization), and then before and after each phase. The study will be conducted by the Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia.
Participants will consume 30g of raw, unsalted almonds for 5 days a week. In the control phase participants will be given 250ml bottled water as an attention control. Participants will be provided with individual packets of almonds (5 days x 8 weeks = 40 packets). During the control phase participants will be asked not to consume nuts or nut products. In the almond phase participants will be asked not to consume nuts or nut products other than the almonds provided.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83178 0
A/Prof Alison Coates
Address 83178 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country 83178 0
Australia
Phone 83178 0
+61 8 83022313
Fax 83178 0
Email 83178 0
alison.coates@unisa.edu.au
Contact person for public queries
Name 83179 0
A/Prof Alison Coates
Address 83179 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country 83179 0
Australia
Phone 83179 0
+61 8 83022313
Fax 83179 0
Email 83179 0
alison.coates@unisa.edu.au
Contact person for scientific queries
Name 83180 0
A/Prof Alison Coates
Address 83180 0
University of South Australia
Alliance for Research in Exercise, Nutrition and Activity (ARENA)
GPO Box 2471, Adelaide, SA 5001
Country 83180 0
Australia
Phone 83180 0
+61 8 83022313
Fax 83180 0
Email 83180 0
alison.coates@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary