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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimisation and validation of a nutritional intervention to enhance sleep quality and quantity
Scientific title

Optimisation and validation of a nutritional intervention to modify sleep quality and quantity in healthy male adults.
Secondary ID [1] 301796 0
PEP-1420
Universal Trial Number (UTN)
U1111-1255-4182
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Optimisation of sleep 318273 0
Condition category
Condition code
Alternative and Complementary Medicine 316289 316289 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318100 0
Treatment: Other
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).
Control group
Placebo

Outcomes
Primary outcome [1] 324459 0
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.
Timepoint [1] 324459 0
Overnight Sleep measured each night between 21:00 and 09:00 after consuming the nutritional intervention (i.e on three occasions).
Secondary outcome [1] 384718 0
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.
Timepoint [1] 384718 0
Cognitive performance was measured at 09.00 the following morning after the nutritional intervention and within 1 hour of waking.
Secondary outcome [2] 384719 0
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.
Timepoint [2] 384719 0
Postural sway was measured at 09.00 the following morning after the nutritional intervention and within 1 hour of waking.

Eligibility
Key inclusion criteria
Males aged 18-40 with no history of a sleep disorder or taking any medication during the time of testing.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a
statistic book
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/10/2017
Date of last participant enrolment
Anticipated
Actual
1/12/2017
Date of last data collection
Anticipated
Actual
11/12/2017
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 30776 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 306229 0
Commercial sector/Industry
Name [1] 306229 0
PepsiCo Inc
Country [1] 306229 0
United States of America
Primary sponsor type
Government body
Name
Australian Institute of Sport
Address
1 Leverrier Cresent
Bruce
ACT 2617
Country
Australia
Secondary sponsor category [1] 306710 0
None
Name [1] 306710 0
Address [1] 306710 0
Country [1] 306710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306440 0
Australian Institute of Sport Ethics Committee
Ethics committee address [1] 306440 0
Ethics committee country [1] 306440 0
Australia
Date submitted for ethics approval [1] 306440 0
03/09/2013
Approval date [1] 306440 0
21/10/2013
Ethics approval number [1] 306440 0
20131003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103882 0
A/Prof Shona Halson
Address 103882 0
Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
Country 103882 0
Australia
Phone 103882 0
+61 422224491
Fax 103882 0
n/a
Email 103882 0
shona.halson@acu.edu.au
Contact person for public queries
Name 103883 0
Shona Halson
Address 103883 0
Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
Country 103883 0
Australia
Phone 103883 0
+61 422224491
Fax 103883 0
n/a
Email 103883 0
shona.halson@acu.edu.au
Contact person for scientific queries
Name 103884 0
Shona Halson
Address 103884 0
Australian Catholic University
School of Behavioural and Health Sciences
1100 Nudgee Rd, Banyo QLD 4014
Country 103884 0
Australia
Phone 103884 0
+61 422224491
Fax 103884 0
n/a
Email 103884 0
shona.halson@acu.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 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.