Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000378527p
Ethics application status
Submitted, not yet approved
Date submitted
21/02/2024
Date registered
2/04/2024
Date last updated
2/04/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Meal timing, sleep & Health Outcomes in different Chronotypes (early birds/ intermediate/ night owls)
Scientific title
The effect of meal timing modification on sleep quality and other health outcomes in morning, intermediate, and evening chronotypes in Adults 18-45 years old
Secondary ID [1] 311571 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep 332944 0
gut dysbiosis 333143 0
Oral dysbiosis 333144 0
blood pressure 333145 0
metabolic status 333146 0
Condition category
Condition code
Diet and Nutrition 329659 329659 0 0
Other diet and nutrition disorders
Cardiovascular 329842 329842 0 0
Hypertension
Oral and Gastrointestinal 329843 329843 0 0
Normal oral and gastrointestinal development and function
Metabolic and Endocrine 329844 329844 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 early chronotype, 10 intermediate and 10 evening type participants will be randomly enrolled in this cross-over trial. Each participant’s usual sleep time would be determined by actigraphy and the instructions about timing of their meals (the time interval between meal consumption and sleep) would be based on their personal usual sleep time.
Arm 1 (control group):
Participants of the early meal group will be instructed to have their dinner 4 hours prior to going to bed,
Arm 2 (intervention):
Participants of the late meal group will take their dinner 1 hour prior to sleep.

The intervention will go on for 3 consecutive days, followed by 11 days of washout. participants will continue their usual timing of other meals taken throughout the day and physical activity. There would be no instructions regarding the content of the meals and participants can choose their own meals. Compliance will be monitored throughout the study by submission of food and sleep diary on RedCap throughout the trial. Participants will wear an actigraph watch and will be asked to record their sleep and dietary intake during the intervention and washout period.
Intervention code [1] 328024 0
Lifestyle
Comparator / control treatment
In this cross-over trial the early meal group is considered as the control group. Participants of this group will be instructed to eat their supper 4 hours prior to going to bed, for 3 consecutive night.
Control group
Active

Outcomes
Primary outcome [1] 337446 0
sleep quality, composite outcome (objectively assessed)
Timepoint [1] 337446 0
1 to 7 days prior to the commencement of intervention (primary time point), throughout the intervention period, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Primary outcome [2] 337611 0
sleep quality (Subjectively assessed)
Timepoint [2] 337611 0
1 to 7 days prior to the commencement of intervention (primary time point), throughout the intervention period, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Primary outcome [3] 337742 0
Sleep quantity
Timepoint [3] 337742 0
1 to 7 days prior to the commencement of intervention (primary time point), throughout the intervention period, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [1] 431876 0
Serum glucose
Timepoint [1] 431876 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [2] 431877 0
Gut microbiota
Timepoint [2] 431877 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [3] 431878 0
Short-chain fatty acid (SCFA) Acetate as a microbial metabolite
Timepoint [3] 431878 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [4] 431880 0
Heart rate
Timepoint [4] 431880 0
1 to 7 days prior to the commencement of intervention, throughout the intervention period, and 1 day after the end of each intervention
Secondary outcome [5] 431882 0
Blood pressure
Timepoint [5] 431882 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [6] 432508 0
Short-chain fatty acid (SCFA) butyrate as a microbial metabolite
Timepoint [6] 432508 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [7] 432509 0
Short-chain fatty acid (SCFA) lactate as a microbial metabolite
Timepoint [7] 432509 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [8] 432510 0
Short-chain fatty acid (SCFA) propionate as a microbial metabolite
Timepoint [8] 432510 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [9] 432517 0
Oral microbiota
Timepoint [9] 432517 0
1 to 7 days prior to the commencement of intervention, and 1 to 3 days after the end of each intervention, depending on when participant provides these samples.
Secondary outcome [10] 432519 0
Serum insulin
Timepoint [10] 432519 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [11] 432520 0
HOMA-IR
Timepoint [11] 432520 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [12] 432521 0
Serum triglyceride (TG)
Timepoint [12] 432521 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [13] 432522 0
Serum low-density lipoprotein (LDL)
Timepoint [13] 432522 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [14] 432523 0
Serum high-density lipoprotein (HDL)
Timepoint [14] 432523 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.
Secondary outcome [15] 432524 0
Serum total Cholesterol
Timepoint [15] 432524 0
1 to 7 days prior to the commencement of intervention, and 1-3 days after the end of each intervention, depending on when participant schedules the appointment.

Eligibility
Key inclusion criteria
Understand English
Adults 18-45 years old (older ages could affect the gut microbiota)
Healthy (no acute or chronic disorders)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Shift working
Diagnosed sleep disorders such as insomnia, sleep apnea, etc.
Taking medication affecting sleep including melatonin, Zolpidem, Lorazepam, antidepressants, etc.
Pregnancy or lactating for women
Yoyo dieting and changing their usual diet during the past month
having observed blood in their stool during the past month
Use of antibiotics during the past 3 months
Metformin consumption during the past 3 months
Having travelled across time zones during the past month

*Not turning up for any of the 3 time-point assessments will be considered a drop out.

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)
The statistician will generate the codes and provide the codes in envelopes to conceal allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A code list will be generated by the online randomization list generator (https://www.sealedenvelope.com). Participants will be allocated to either of the early meal or late meal intervention groups through stratified block randomization (stratification based on chronotype).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Descriptive statistics will be used to report demographic data. Continuous variables will be reported as mean (SD). Categorical variables will be tested by Chi-square or Fisher’s exact test (frequency (%)).
ANOVA test will be used to compare baseline characteristics of the three groups and a 2 factor ANCOVA with one factor (between group) Chronotype and second factor (within group) timing of meal, with adjustment for variables that are statistically different at the baseline. Posthoc analyses such as Bonferroni or Tukey tests can be used to identify differences when ANCOVA (with adjustment for covariates and confounders) results are significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315871 0
University
Name [1] 315871 0
The University of Sydney
Country [1] 315871 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318014 0
None
Name [1] 318014 0
None
Address [1] 318014 0
Country [1] 318014 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314719 0
The University of Sydney HREC 2
Ethics committee address [1] 314719 0
Ethics committee country [1] 314719 0
Australia
Date submitted for ethics approval [1] 314719 0
20/12/2023
Approval date [1] 314719 0
Ethics approval number [1] 314719 0

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

Contacts
Principal investigator
Name 132510 0
Dr Cin Moi Chow
Address 132510 0
The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Camperdown, NSW, 2050
Country 132510 0
Australia
Phone 132510 0
+61 2 9351 9332
Fax 132510 0
Email 132510 0
[email protected]
Contact person for public queries
Name 132511 0
Zohreh Sajadi Hezaveh
Address 132511 0
The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Camperdown, NSW, 2050
Country 132511 0
Australia
Phone 132511 0
+61 2 9351 9576
Fax 132511 0
Email 132511 0
[email protected]
Contact person for scientific queries
Name 132512 0
Cin Moi Chow
Address 132512 0
The University of Sydney, Faculty of Medicine and Health, School of Health Sciences, Camperdown, NSW, 2050
Country 132512 0
Australia
Phone 132512 0
+61 2 9351 9332
Fax 132512 0
Email 132512 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
No IPD sharing could be approved under the ethics approval for this study.


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.