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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06686667




Registration number
NCT06686667
Ethics application status
Date submitted
4/11/2024
Date registered
13/11/2024
Date last updated
29/06/2025

Titles & IDs
Public title
The Feasibility of Overnight Time Restricted Eating and Impact on Glucose Levels in Shift Workers
Scientific title
The Effect of Overnight Time Restricted Eating on Glucose Regulation in Rotating Shift Workers - A Randomised Controlled Feasibility Trial
Secondary ID [1] 0 0
2024/ETH01526
Universal Trial Number (UTN)
Trial acronym
TREsh
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shift Work 0 0
Eating Behaviors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Time Restricted Eating

Experimental: Time Restricted Eating - Participants will follow a time-restricted eating diet during day and night shifts over 2 weeks

No intervention: Control Arm - Participants will follow their usual eating patterns without restrictions during day and night shifts over 2 weeks


BEHAVIORAL: Time Restricted Eating
The intervention arm will consist of a time-restricted eating protocol with fasting between 11:00 PM to 6:00 AM. Ad libitum eating will be allowed outside these times and the protocol will be administered during day and night shifts over a 2 week period.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of time-restricted eating (TRE) among shift workers (Recruitment and Participation Rate)
Timepoint [1] 0 0
From enrolment to end of treatment at 2 weeks
Primary outcome [2] 0 0
Feasibility of time-restricted eating (TRE) among shift workers (Adherence Rate)
Timepoint [2] 0 0
Two weeks
Primary outcome [3] 0 0
Feasibility of time-restricted eating (TRE) among shift workers (Study Completion Rate)
Timepoint [3] 0 0
Two weeks
Secondary outcome [1] 0 0
Blood glucose levels during the 2-week study period
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Facilitators and barriers associated with adherence to time restricted eating
Timepoint [2] 0 0
2 weeks

Eligibility
Key inclusion criteria
* Healthcare professionals engaged in rotating shift work, including night shifts;
* Aged 23-60 years;
* At least 12 months experience in shift work;
* Willing to wear continuous glucose monitor sensors;
* Willing to engage in time restricted eating.
Minimum age
23 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Diagnosis of diabetes (Type 1 or 2), any bariatric surgery, coeliac disease, inflammatory bowel disease, endocrine disorders affecting glucose metabolism, current or history of eating disorder, any liver, kidney, or coronary heart disease, obese (BMI>35) or underweight (BMI< 18) or any severe or unstable chronic medical conditions or cancers;
* Currently taking medications known to interact with glucose metabolism, i.e. thyroxin, insulin sensitizers, glucocorticoids, or anti-depressants, weight loss medication;
* Undertaking current structured or restrictive dietary plan;
* Shift workers who routinely do not eat between 23:00 and 06:00 hours during night shift;
* Current or planned pregnancy or currently breast feeding;
* Consume three or more standard alcohol containing beverages on a single occasion almost every day;
* People who identify as having significant caffeine dependency and are unwilling to limit intake of calorie free energy drinks;
* People with planned travel over time zones during the study period
* Any contraindication to use of Abott FreeStyle Libre Pro glucose sensor (eg prescription of vitamin C, Salicylic acid or paracetamol - to be reviewed by study clinician).

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)
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/07/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 0 0
2229 - Caringbah

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
South Eastern Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Christopher J Gordon, PhD
Address 0 0
Woolcock Institute of Medical Research and Macquarie University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be dei-dentified using a unique study ID.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06686667