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Trial registered on ANZCTR
Registration number
ACTRN12620000884909
Ethics application status
Approved
Date submitted
16/07/2020
Date registered
7/09/2020
Date last updated
7/09/2020
Date data sharing statement initially provided
7/09/2020
Date results information initially provided
7/09/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Optimisation and validation of a nutritional intervention to enhance sleep quality and quantity
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Scientific title
Optimisation and validation of a nutritional intervention to modify sleep quality and quantity in healthy male adults.
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Secondary ID [1]
301796
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PEP-1420
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Universal Trial Number (UTN)
U1111-1255-4182
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Optimisation of sleep
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Condition category
Condition code
Alternative and Complementary Medicine
316289
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention provided was a combination of nutritional ingredients designed to influence sleep. Three interventions were provided:
1. A optimised combination of nutritional ingredients intended to enhance sleep
2. A least optimised combination of nutritional ingredients intended to enhance sleep (i.e. have a reduced positive effect in comparison to 1).
3. Placebo
The duration of each intervention was 1 night per intervention, performed on three consecutive nights. Including a familiarisation night at the beginning of the study (where no intervention was provided), the total duration was 4 nights in the sleep laboratory. Participants stayed for 4 nights and 4 days in the laboratory and consumption of the intervention was observed by a study supervisor. Participants were allowed outside twice per day for group, supervised light exercise.
For the duration of the study and including the provision of the intervention, participants were housed in a purpose-built accommodation suite at Central Queensland University’s Appleton Institute. This ensured control over dietary intake and physical activity.
The ingredients and their source were:
1. Tart Cherry Juice (Cherry Active Australia)
2. Glucose (PolyJoule, Australia)
3. alpha-lactalbumin (Davisco Foods, USA)
4. Adenosine-5-monophosphate (5-AMP)- (Sigma, USA)
5. Valerian (Martin Baeur Group, Germany)
6. Theanine (Sun Theanine, Japan)
The combination and dosage of the above ingredients for the 3 trials were:
1) Most optimal combination: 10g glucose, 40g alpha-lactalbumin, 655mg theanine, 53 mg 5'AMP, and 600mg of valerian.
2) Least optimal combination: 35ml tart cherry, 45g glucose, 8g alpha-lactalbumin, 1000mg theanine, 4.5mg 5'AMP, and 500mg of valerian.
3) Placebo: artificially flavoured and coloured water
These ingredients were mixed together by a qualified dietitian with over 10 years experience (independent to the study authors) and added to 250ml of water The intervention was provided in person to participants by a member of the study team. On each night, participants consumed the intervention at 21:00h and were instructed to consume it within 5 min.
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Intervention code [1]
318100
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Treatment: Other
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Comparator / control treatment
The optimal and least optimal combination of ingredients were compared to a placebo. This consisted of artificially flavoured (cherry flavouring) and coloured water (red food colouring).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome was overnight sleep measured the night immediately after consuming the nutritional intervention at 21:00. Overnight sleep was a composite of: sleep onset latency (time taken to fall asleep) and sleep stages (Rapid Eye Movement (REM) and non-REM stages.
Sleep was recorded using polysomnography equipment (Grael; Compumedics, Melbourne, VIC) with a standard montage of electrodes. Electrodes were applied in the 60 min prior to lights out and included three electroencephalograms (C4-M1, F4-M1, O2-M1), two electrooculograms (left/right outer canthus), and a submental electromyogram. All sleep records were blinded and manually scored in 30-s epochs by the same technician according to established criteria. Stages of sleep were identified as non-rapid eye movement sleep (stages N1, N2, N3) and rapid eye movement sleep (R), with N1 considered the lightest phase of sleep and N3 considered the deepest phase.
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Assessment method [1]
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Timepoint [1]
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Overnight Sleep measured each night between 21:00 and 09:00 after consuming the nutritional intervention (i.e on three occasions).
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Secondary outcome [1]
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Cognitive performance
Cognitive performance was assessed using the psychomotor vigilance task (PVT-192; Ambulatory Monitoring Inc., New York, USA). The PVT is a hand-held device with an upper surface that contains a four-digit LED display and two push-button response keys. Participants attended to the LED display for the duration of the test (10 minutes) and pressed the appropriate response key with the thumb of their dominant hand as quickly as possible after the appearance of a visual stimulus (presented at a variable interval of 2-10 seconds). If the correct response key was pressed, the LED display exhibited the participant’s response time, in milliseconds, for 500 milliseconds. If the wrong response key was pressed, an error message was displayed (ERR). If a response was made prior to the stimulus being presented, a false start message was displayed (FS). The composite measures derived from the PVT included response time (ms); the number of lapses (i.e., response latency exceeding 500 milliseconds) and the number of errors (i.e., false starts and incorrect button pushes). For all analyses, anticipated responses (i.e., those with response time less than 100 milliseconds) were excluded. Cognitive throughput was assessed using a computer-based visual spatial-configuration search task.. The task is self-paced and consists of 52 trials in which participants are required to search for a target (i.e., the number 5) amongst distractors (i.e., the number 2). Visual searches were performed for set sizes of 10, 20, 30, or 40 distractor stimuli. Set size was equally distributed across the task. The dependent variables obtained from the task were the number of errors and the time taken to complete the task.
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Assessment method [1]
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Timepoint [1]
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Cognitive performance was measured at 09.00 the following morning after the nutritional intervention and within 1 hour of waking.
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Secondary outcome [2]
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Postural sway
Postural sway was assessed using an Accusway computerized force platform (AMTI, Watertown, MA) in conjunction with Swaywin software (AMTI, Watertown, MA). The force platform measures the three-dimensional forces (Fx, Fy, Fz) and the three-dimensional moments (Mx, My, Mz) involved in balance. These provide centre of pressure (COP) coordinates, which allow postural sway to be calculated. Participants performed two postural balance tasks each for 30 seconds – standing still with eyes open and standing still with eyes closed. The dependent variable obtained from the task was the area of the 95% confidence ellipse enclosing the COP.
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Assessment method [2]
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Timepoint [2]
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Postural sway was measured at 09.00 the following morning after the nutritional intervention and within 1 hour of waking.
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Eligibility
Key inclusion criteria
Males aged 18-40 with no history of a sleep disorder or taking any medication during the time of testing.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a
statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size calculations were based on previous studies examining tryptophan on sleep in healthy individuals as well as the numbers of beds available at any one time in the sleep laboratory (multiples of 6). Therefore 18 subjects were recruited.
All data were analysed with a General Linear Mixed Model using the R package lme4 (R Core Team). A random intercept for ‘subjects’ was included to account for intraindividual dependencies and interindividual heterogeneity. All models were estimated using Restricted Maximum Likelihood. Data points with a value that was greater than 2 standard deviations from the mean were removed. Visual inspection of residual plots did not reveal any obvious deviations from homoscedasticity but showed indications of heavy tails against the normal distribution. This was accommodated by obtained bootstrapped confidence intervals. P-values were obtained using Type II Wald F tests with Kenward-Roger degrees of freedom as implemented in the R package. Results are reported as mean estimates and 95% confidence intervals
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
31/10/2017
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Date of last participant enrolment
Anticipated
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Actual
1/12/2017
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Date of last data collection
Anticipated
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Actual
11/12/2017
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Sample size
Target
18
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment postcode(s) [1]
30776
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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PepsiCo Inc
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Address [1]
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5600 Headquarters Dr, Plano, TX 75024, United States
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Country [1]
306229
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United States of America
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Primary sponsor type
Government body
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Name
Australian Institute of Sport
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Address
1 Leverrier Cresent
Bruce
ACT 2617
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306710
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Address [1]
306710
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Country [1]
306710
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Australian Institute of Sport Ethics Committee
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Ethics committee address [1]
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1 Leverrier Cresent
Bruce
ACT 2617
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/09/2013
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Approval date [1]
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21/10/2013
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Ethics approval number [1]
306440
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20131003
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Summary
Brief summary
The aim of this study was to investigate whether a nutritional intervention could enhance sleep by determining the effects on sleep quantity and quality as well as balance and cognitive function in healthy adults.
Three trials were performed where different combinations of ingredients were provided and compared to a placebo in 18 healthy male participants.
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Trial website
N/a
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Trial related presentations / publications
N/a
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Shona Halson
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Address
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Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
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Country
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Australia
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Phone
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+61 422224491
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Fax
103882
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n/a
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Email
103882
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[email protected]
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Contact person for public queries
Name
103883
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A/Prof Shona Halson
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Address
103883
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Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
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Country
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Australia
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Phone
103883
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+61 422224491
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Fax
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n/a
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Email
103883
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Shona Halson
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Address
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Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
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Country
103884
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Australia
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Phone
103884
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+61 422224491
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Fax
103884
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n/a
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Email
103884
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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