Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001556437
Ethics application status
Approved
Date submitted
28/10/2016
Date registered
10/11/2016
Date last updated
20/10/2022
Date data sharing statement initially provided
27/11/2018
Date results provided
2/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of night eating during simulated shift work on metabolism, cognitive performance and mood in healthy adults
Scientific title
In healthy adults, what is the impact of eating at night (compared to not eating at night) on metabolism, cognitive performance and mood during simulated night shift?
Secondary ID [1] 290408 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Performance 300746 0
Metabolic Health 300747 0
Condition category
Condition code
Diet and Nutrition 300578 300578 0 0
Other diet and nutrition disorders
Mental Health 300579 300579 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 300580 300580 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A simulated shift work protocol, with one 8h night time baseline sleep, followed by 4 consecutive days of simulated shift work (sleep from 10:00-16:00 each day), and an 8h night time recovery sleep on day 6. An OGTT will be conducted pre and post simulated night shift and serum samples will be collected to assess markers of metabolic risk . During simulated night shift (22:00-06:00) participants completed a number of performance based assessment tasks including simulated driving and a neural behavioural test battery. A parallel study design was implemented, whereby participants were randomly allocated to one of three conditions; meal at night, snack at night, or control. These meal schedules were provided on days 3-6 (simulated shift schedule days). On Day 1 (adaptation), Day 2 (baseline) and Day 7 (recovery), a standard meal schedule was adhered to (morning breakfast meal, noon lunch meal and evening dinner meal).

Meals: Meal at night condition- morning 07:00 (toast, cereal etc), late afternoon 19:00 (sandwiches etc) and night 01:30 (mixed dishes, salad, veg etc); Snack at night condition- morning 07:00 (toast, cereal etc), afternoon 17:00 (sandwiches etc), late afternoon 19:00 (mixed dishes, salad, veg, etc) and night 01:30 (fruit, crackers, etc). The diet is a standardised diet typical of the Australian diet. The energy content of the meals was based on individual daily dietary energy requirements (kJ) calculated using the Harris Benedict equation with a light/sedentary activity level (laboratory condition). Energy intake was consistent across conditions per 24 hour period. All food provided was weighed and recorded pre and post consumption. Participants were allowed access to water ad libitum.

During the protocol participants were supervised by at least two research assistants at all times. A combination of actigraphy watches and polysomnography were used to monitor sleep. Physical activity was kept to a minimum in the laboratory.
Intervention code [1] 296239 0
Behaviour
Intervention code [2] 296240 0
Lifestyle
Comparator / control treatment
A simulated shift work protocol , with one 8h night time baseline sleep, followed by 4 consecutive days of simulated shift work (sleep from 10:00-16:00 each day), and an 8h night time recovery sleep on day 6. During simulated night shift (22:00-06:00) participants completed a number of performance based assessment tasks including simulated driving and a neural behavioural test battery.

Meals: morning 07:00 (toast, cereal etc), mid-morning 09:30 and mid-afternoon 14:00 (fruit, muffins, crackers etc) and night 19:00 (mixed dishes, salad, veg etc). The diet was a standardised diet typical of the Australian diet. The energy content of the meals was based on individual daily dietary energy requirements (kJ) calculated using the Harris Benedict equation with a light/sedentary activity level (laboratory condition). All food provided was weighed and recorded pre and post consumption. Participants were allowed access to water ad libitum.

During the protocol participants were supervised by at two research assistants at all times. A combination of actigraphy watches and polysomnography were used to monitor sleep. Physical activity was kept to a minimum in the laboratory.
Control group
Active

Outcomes
Primary outcome [1] 299997 0
Serum samples for glucose analysis will be collected to assess markers of metabolic risk at regular intervals pre and post OGTT.
Timepoint [1] 299997 0
-15, 0 minutes pre- and 15, 30, 60, 90, 120 and 150 minutes post-OGTT on days 2 (baseline) and 7 (recovery)'
Primary outcome [2] 299998 0
Serum samples for insulin analysis will be collected to assess markers of metabolic risk at regular intervals pre and post OGTT.
Timepoint [2] 299998 0
-15, 0 minutes pre- and 15, 30, 60, 90, 120 and 150 minutes post-OGTT on days 2 (baseline) and 7 (recovery)'
Primary outcome [3] 299999 0
Serum samples for free fatty acid analysis will be collected to assess markers of metabolic risk at regular intervals pre and post OGTT.
Timepoint [3] 299999 0
-15, 0 minutes pre- and 15, 30, 60, 90, 120 and 150 minutes post-OGTT on days 2 (baseline) and 7 (recovery)'
Secondary outcome [1] 328780 0
Cognitive functioning, assessed by a battery of cognitive tests including: psychomotor vigilance task (vigilant attention task), and driving task
Timepoint [1] 328780 0
Every 2-hours during wake periods on days 2 to 7 (Day 1 is used for acclimatising to the laboratory setting and explaining the tests to participants)
Secondary outcome [2] 328781 0
Markers of sleep quality will be assessed using polysomnography. Some markers of sleep quality are total sleep time, sleep efficiency and slow wave sleep.
Timepoint [2] 328781 0
Day 1 (baseline), Day 5 and Day 6 (recovery)
Secondary outcome [3] 328782 0
Mood, assessed by a battery of cognitive tests including: VAS scales and PANAS.
Timepoint [3] 328782 0
Every 3-hours during wake periods on all days (Day 1 is used for acclimatising to the laboratory setting and explaining the tests to participants)
Secondary outcome [4] 375229 0
Serum samples for liver enzyme analysis will be collected to assess changes in response to multiple night shifts.
Timepoint [4] 375229 0
The blood samples will be taken at 1800 and 2130 on days 2 and 5, and at 0000 and 0600 on days 3 and 6.
Secondary outcome [5] 375230 0
Salivary samples were collected to assess melatonin in response to night shift.
Timepoint [5] 375230 0
Salivary samples were completed approximately every hour during the study protocol
Secondary outcome [6] 375231 0
Serum samples for glucose analysis will be collected to assess markers of metabolic risk at regular intervals pre and post breakfast.
Timepoint [6] 375231 0
-15, 0 minutes pre- and 15, 30, 60, 90, 120 and 150 minutes post-breakfast on days 3 and 6'
Secondary outcome [7] 375232 0
Serum samples for insulin analysis will be collected to assess markers of metabolic risk at regular intervals pre and post breakfast.
Timepoint [7] 375232 0
-15, 0 minutes pre- and 15, 30, 60, 90, 120 and 150 minutes post-breakfast on days 3 and 6'
Secondary outcome [8] 375233 0
Serum samples for metabolomic analysis will be collected to assess changes in response to multiple night shifts.
Timepoint [8] 375233 0
The blood samples will be taken at 1800 and 2130 on days 2 and 5, and at 0000 and 0600 on days 3 and 6.
Secondary outcome [9] 375234 0
Salivary samples were collected to assess cortisol in response to night shift.
Timepoint [9] 375234 0
Salivary samples were completed approximately every hour during the study protocol

Eligibility
Key inclusion criteria
Adults aged 18-45 years, BMI normal to overweight (20-29kg/m2), non-smoker, low alcohol (less than or equal to 2 standard drinks/ day) and caffeine consumption (less than or equal to 2 cups/ day), normal sleep/wake pattern (habitual sleep duration between 7-8 hours a night), stable weight over the preceding 3 months, competent written and spoken English.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who report one or more of the following: habitual napping (more than 1 per week), score of less than 31 or more than 69 in the morningness- eveningness questionnaire, significant depression or physical illness, established using clinical history and Beck Depression Inventory (score equal to or more than 14), food difficulties (example: gluten intolerance or restrained eaters) measured by clinical history, use of medications, including injected, topical or inhaled glucocorticoids, previous shift work history, sleep disorders, history of medical conditions; cardiovascular disease, neurological disorder, kidney disease, liver disease, clinically significant values (as determined by the reviewing study physician) for any hematology or chemistry parameter. Reviewing study licensed physician may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant, currently taking corticosteroid or anti-inflammatory medications.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/06/2016
Date of last participant enrolment
Anticipated
1/12/2020
Actual
4/03/2019
Date of last data collection
Anticipated
31/12/2020
Actual
4/03/2019
Sample size
Target
60
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294816 0
Government body
Name [1] 294816 0
NHMRC
Country [1] 294816 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Sleep and Chronobiology Laboratory
University of South Australia
MC Building, St Bernards Road
Magill Campus
Magill SA 5072
Australia
Country
Australia
Secondary sponsor category [1] 293654 0
Individual
Name [1] 293654 0
Prof Siobhan Banks
Address [1] 293654 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country [1] 293654 0
Australia
Secondary sponsor category [2] 293655 0
Individual
Name [2] 293655 0
A/Prof Alison Coates
Address [2] 293655 0
Division of Health Science
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Australia
Country [2] 293655 0
Australia
Secondary sponsor category [3] 293656 0
Individual
Name [3] 293656 0
Miss Charlotte Gupta
Address [3] 293656 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country [3] 293656 0
Australia
Secondary sponsor category [4] 293657 0
Individual
Name [4] 293657 0
Dr Stephanie Centofanti
Address [4] 293657 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country [4] 293657 0
Australia
Secondary sponsor category [5] 293659 0
Individual
Name [5] 293659 0
A/Prof Jill Dorrian
Address [5] 293659 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country [5] 293659 0
Australia
Secondary sponsor category [6] 293660 0
Individual
Name [6] 293660 0
A/Prof Leonie Heilbronn
Address [6] 293660 0
SAHMRI
North Terrace
PO Box 11060
Adelaide, SA, 5001
Country [6] 293660 0
Australia
Secondary sponsor category [7] 293661 0
Individual
Name [7] 293661 0
Prof Gary Wittert
Address [7] 293661 0
University of Adelaide
Royal Adelaide Hospital, 6th Floor, Eleanor Harrald Building
North Terrace
Adelaide, SA, 5001
Country [7] 293661 0
Australia
Secondary sponsor category [8] 293662 0
Individual
Name [8] 293662 0
Prof Dave Kennaway
Address [8] 293662 0
University of Adelaide
Adelaide SA 5005
Country [8] 293662 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296206 0
University of South Australia
Ethics committee address [1] 296206 0
Ethics committee country [1] 296206 0
Australia
Date submitted for ethics approval [1] 296206 0
Approval date [1] 296206 0
17/10/2014
Ethics approval number [1] 296206 0
0000033621

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

Contacts
Principal investigator
Name 69990 0
Prof Siobhan Banks
Address 69990 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country 69990 0
Australia
Phone 69990 0
+61 08 83021712
Fax 69990 0
Email 69990 0
[email protected]
Contact person for public queries
Name 69991 0
Siobhan Banks
Address 69991 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country 69991 0
Australia
Phone 69991 0
+61 08 83021712
Fax 69991 0
Email 69991 0
[email protected]
Contact person for scientific queries
Name 69992 0
Siobhan Banks
Address 69992 0
Sleep and Chronobiology Laboratory University of South Australia St Bernards Road Magill Campus Magill SA 5072 Australia
Country 69992 0
Australia
Phone 69992 0
+61 08 83021712
Fax 69992 0
Email 69992 0
[email protected]

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.