The Feasibility of Overnight Time Restricted Eating and Impact on Glucose Levels in Shift Workers

NCT06686667 | Completed

• 1 other identifier: 2024/ETH01526
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to assess whether it is feasible for shift workers to follow a time-restricted eating diet. The trial will investigate the impact of time-restricted eating on blood glucose levels during day and night shifts both with and without the time-restricted eating diet. The trial aims are:

• Is it feasible for shift workers to adhere to a night time time-restricted eating protocol?
• How does time-restricted eating affect blood glucose levels during the day and night shifts and over the whole day?

Conditions

Shift Work; Eating Behaviors

Keywords

Shift Worker Health; dietary intervention; time restricted eating; feasibility

Outcome Measures

Primary Outcomes (3)

• Feasibility of time-restricted eating (TRE) among shift workers (Recruitment and Participation Rate)

  Feasibility will be assessed through a composite of the following metrics: Recruitment and participation rate (%) will be assessed as the percentage of participants randomized from the screened population. Each component will be assessed separately but reported as contributing factors to the overall feasibility.

  From enrolment to end of treatment at 2 weeks

• Feasibility of time-restricted eating (TRE) among shift workers (Adherence Rate)

  Feasibility will be assessed through a composite of the following metrics: Adherence rate (%) percentage of participants who comply with the TRE protocol over a 2-week period, determined using self-reports Each component will be assessed separately but reported as contributing factors to the overall feasibility.

  Two weeks

• Feasibility of time-restricted eating (TRE) among shift workers (Study Completion Rate)

  Feasibility will be assessed through a composite of the following metrics: Study completion rate (%) percentage of participants who complete the 2-week study period without dropping out. Each component will be assessed separately but reported as contributing factors to the overall feasibility.

  Two weeks

Secondary Outcomes (2)

• Blood glucose levels during the 2-week study period

  2 weeks

• Facilitators and barriers associated with adherence to time restricted eating

  2 weeks

Study Arms (2)

Time Restricted Eating

EXPERIMENTAL

Participants will follow a time-restricted eating diet during day and night shifts over 2 weeks

Behavioral: Time Restricted Eating

Control Arm

NO INTERVENTION

Participants will follow their usual eating patterns without restrictions during day and night shifts over 2 weeks

Interventions

Time Restricted Eating BEHAVIORAL

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.

Time Restricted Eating

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead
• South Eastern Sydney Local Health District: collaborator

Study Sites (1)

The Sutherland Hospital

Caringbah, New South Wales, 2229, Australia

Location

MeSH Terms

Conditions

Feeding Behavior; Intermittent Fasting

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Fasting

Study Officials

• Christopher J Gordon, PhD

  Woolcock Institute of Medical Research and Macquarie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label trial assessing a behavioral eating intervention

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 13, 2024
• Study Start: March 24, 2025
• Primary Completion: July 10, 2025
• Study Completion: September 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)