Intermittent Fasting in Shift-workFastingClocksNCT07451132
Time-restricted Eating and Circadian Health in Night Shift Workers
A study testing Time-restricted eating in people with Intermittent Fasting in Shift-work, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting in Shift-work
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 30 Oct 2023to 11 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
- Having traveled across time zones (at any time during the last month) and planning travel during the study
- Pregnant or intend to become pregnant, and
- Lactating women
Trial locations and contacts
1 site in 1 country.
Chile1 site
Faculty of Medicine, University of Chile
Santiago, Metropolitan Region, 8380453
About this study
Official title: Effect of a Time-restricted Eating Protocol on Glucose Homeostasis, Markers of Circadian System, Appetite Control, and Oxidative Stress Parameters in Night Shift Workers
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.
Read the 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
- Intermittent Fasting in Shift-work
- Being tested
- Time-restricted eating
- Keywords
- time-restricted eating, shiftwork, intermittent fasting, healthcare
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
24-h glycemic control (expressed in mg/dL), measured with continuous glucose monitoring (CGM) using a portable capillary glucose sensor, over 10 consecutive days.
Measured: From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)
24-hour motor activity level (counts/min)
Motor activity will be assessed by accelerometric recordings (actigraphic data) of wrist activity. Actigraphy data will assess motor activity before and after the intervention
Measured: 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
Clock-gene expression will be evaluated by relative expression, performing RT-stem loop real-time PCR, from fasting whole-blood samples taken at baseline and after 8 weeks, in each study period. Gene expression levels of the target sequences will be normalized to the expression of GAPDH, and will be calculated by applying equation 2-∆∆ CT.
Measured: 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
TBARS level (in µM/ml) will be measured in plasma samples
Measured: 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
F-8 isoprostane level (in pg/mL) will be measured in plasma samples
Measured: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from Baseline in Appetite-related feelings at 8 weeks
A visual analog scale will be used to assess appetite feeling levels. Each participant rates their subjective feelings of appetite, satiety, and desire to eat using a 100 mm visual analog scale, with endpoints indicating from "not at all" (0 mm) to "extremely" (100 mm).
Measured: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in total-, reduced- and oxidized glutathione levels at 8 weeks
Total-, reduced-, and oxidized glutathione levels (in µM) will be measured in plasma samples
Measured: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in C-reactive protein levels at 8 weeks
C-reactive protein levels (in mg/L) will be measured in serum samples
Measured: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in pro-inflammatory cytokine levels at 8 weeks
Interleukin 1β, Interleukin 6, and Tumor necrosis factor (TNF-α) levels (in pg/mL) will be measured in plasma samples.
Measured: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 Oct 2023
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Fasting in Shift-workStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Rodrigo Chamorro, University of Chile
- Investigators
- Lucía Cifuentes, MD, Study chair, Ethics Committee for Human Subjects of the Faculty of Medicine, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451132
- Sponsor's protocol ID
- TRE-Shift-2024
- Acronym
- FastingClocks
- Status last verified
- May 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Published data generated from the study will be available from the leading author, upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Time-restricted Eating Protocol on Glucose Homeostasis, Markers of Circadian System, Appetite Control, and Oxidative Stress Parameters in Night Shift Workers
- ClinicalTrials.gov ID
- NCT07451132
- Acronym / sponsor ID
- FastingClocks / TRE-Shift-2024
- Conditions
- Intermittent Fasting in Shift-work
- Keywords
- time-restricted eating, shiftwork, intermittent fasting, healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingSelf-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). |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-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 | Behavioural | Time-restricted eating |
Primary outcome
Change from Baseline in the mean fasting glycemia at 8 weeks
Time frame: From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)
Fasting glycemia level (in mg/dL) will be measured from fasting blood samples and measured with the hexokinase method
9 secondary outcomes
Change from baseline to end of treatment (8weeks) in 24-h glycemic control
Time frame: From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)
24-hour motor activity level (counts/min)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from Baseline in Appetite-related feelings at 8 weeks
Time frame: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in total-, reduced- and oxidized glutathione levels at 8 weeks
Time frame: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in C-reactive protein levels at 8 weeks
Time frame: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Change from baseline in pro-inflammatory cytokine levels at 8 weeks
Time frame: From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Published data generated from the study will be available from the leading author, upon reasonable request
Related trials for Intermittent Fasting in Shift-work
Recruiting
Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
Night Shift Work, Time Restricted Eating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucía Cifuentes, MD study chair
Ethics Committee for Human Subjects of the Faculty of Medicine, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Intermittent Fasting in Shift-work, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the mean fasting glycemia at 8 weeks (time frame: From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.