Clinical Trials Directory

Trials / Completed

CompletedNCT07451132

Time-restricted Eating and Circadian Health in Night Shift Workers

Effect of a Time-restricted Eating Protocol on Glucose Homeostasis, Markers of Circadian System, Appetite Control, and Oxidative Stress Parameters in Night Shift Workers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Chile · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Detailed description

This is a randomized, crossover, controlled, within-subject study. After recruitment, participants will be randomized to one of two conditions: i) Time-restricted eating (TRE), with an eating window of 10 hours per day but without any other diet modification (e.g., types of food or amount of energy consumed). Each participant can freely choose the starting time of their eating window. If a participant need to make modifications to the start time of their eating window, he/she may do so only once during the TRE period, and the research team must be informed. After a washout period of at least 30 days, participants will undergo ii) Regular eating (REG), during which the participants must maintain their usual eating pattern (i.e., usual eating window), without making any dietary or lifestyle changes. Each condition will have a duration of 8 weeks. Randomization will be done using computer-generated random numbers.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTime-restricted eatingDuring 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

Timeline

Start date
2023-10-30
Primary completion
2025-07-11
Completion
2025-07-11
First posted
2026-03-05
Last updated
2026-03-05

Locations

1 site across 1 country: Chile

Source: ClinicalTrials.gov record NCT07451132. Inclusion in this directory is not an endorsement.