Time-restricted Eating and Circadian Health in Night Shift Workers

NCT07451132 | Completed

• 1 other identifier: TRE-Shift-2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the effect of time-restricted eating (TRE) to 10 hours per day on glucose homeostasis, markers of the circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress status in night shift workers. The main questions it aims to answer are: 1) How does a time-restricted eating protocol affect glucose homeostasis in shift workers? and 2) How does a time-restricted eating protocol affect markers of the circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress status in shift workers? Participants will be asked to follow a TRE protocol on which they must restrict their eating to a self-selected time window of 10 hours a day, with mandatory fasting time between 24:00-06:00h. for 8 weeks. Researchers will compare the intervention with an additional period of 8 weeks, in which the participants will follow their usual diet without any time restriction, to see if the intervention improves glucose regulation appetite and markers of circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress.

Conditions

Intermittent Fasting in Shift-work

Keywords

time-restricted eating; shiftwork; intermittent fasting; healthcare

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the mean fasting glycemia at 8 weeks

  Fasting glycemia level (in mg/dL) will be measured from fasting blood samples and measured with the hexokinase method

  From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)

Secondary Outcomes (9)

• Change from baseline to end of treatment (8weeks) in 24-h glycemic control

  From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)

• 24-hour motor activity level (counts/min)

  From enrollment to the end of treatment (at 8 weeks), in each study period (TRE and REG)

• Change from Baseline in the circadian clock-genes expression at 8 weeks

  From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)

• Change from baseline in thiobarbituric acid reactive substances (TBARS) level at 8 weeks

  From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)]

• Change from baseline in F-8 isoprostane level at 8 weeks

  From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)

Other Outcomes (7)

• Change in body mass index at 8 weeks

  From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)

• Change from baseline in fat mass index at 8 weeks

  From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)

• Change from Baseline in sleep duration at 8 weeks

  From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Self-selected eating window of 10 hours per day without any other dietary modification (e.g., types of food or amount of energy consumed) for 8 weeks, with 14 hours fasting per day (mandatory fasting from 00:00h until 06:00h).

Behavioral: Time-restricted eating

Regular eating

NO INTERVENTION

Participants must maintain their usual eating pattern (i.e., usual eating window) for 8 weeks, but without any dietary or lifestyle changes

Interventions

Time-restricted eating BEHAVIORAL

During the intervention (TRE) each participant will freely choose the starting time of their eating window. If needed, participant can modify the selected start time of their eating window only once during the intervention period, and the research team must be informed. After a washout period of at least 30 days, participants will undergo the opposite condition (TRE or Regular eating) after the initial randomization

Time-restricted eating

Eligibility Criteria

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

You may qualify if:

• Adults (range 18 - 60 yrs.) Men and women Performing as a healthcare worker Being a shift-worker for at least 6 months in the current schedule Working in rotating shiftwork, including at least one night shift Reporting no work-related performance difficulties

You may not qualify if:

• Current and chronic neurological disorders
• Pathologies related to abnormal adrenal activity
• Liver or kidney disease
• Uncontrolled hypertension, dyslipidemia, and thyroid disease
• Insulin resistance and T2D
• BMI ≥40 kg/m2
• Use of medications known to alter body composition, such as insulin sensitizers, glucocorticoids, or anti-depressants
• Autoimmune diseases with acute symptoms; recent surgery of any kind (in the last 3 months);
• Acute, chronic inflammation (usCRP \>10 mg/L)
• Following any dietary restriction (special diet) in the previous three months
• Having a short sleep (habitual sleep duration of less than 6h per day)
• History of bariatric surgery
• Depression (Beck Depression Inventory) or sleep disorders (Pittsburgh Sleep Questionnaire)
• Night-eating syndrome (Night Eating Questionnaire)
• Intense exercise level (\>3 days/week of high-intensity exercise)

Sponsors & Collaborators

• University of Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Faculty of Medicine, University of Chile

Santiago, Metropolitan Region, 8380453, Chile

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Lucía Cifuentes, MD

  Ethics Committee for Human Subjects of the Faculty of Medicine, University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: March 5, 2026
• Study Start: October 30, 2023
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)