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| Name | Class |
|---|---|
| Agencia Nacional de Investigación y Desarrollo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index at 8 weeks | Body mass index will be calculated (expressed as kg/m2) from body weight and height anthropometric measurements, measured with light clothes and expressed as Kg (weight) and cm (height), respectively. | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucía Cifuentes, MD | Ethics Committee for Human Subjects of the Faculty of Medicine, University of Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University of Chile | Santiago | Metropolitan Region | 8380453 | Chile |
Published data generated from the study will be available from the leading author, upon reasonable request
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
| 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 |
| 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. | 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 | 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 | 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). | 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 | 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 | 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. | 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 |
Fat mass index (in kg/m²) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer |
| 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 | Sleep duration will be measured through continuous actigraphic recordings during daytime and nighttime for 10 days, and expressed in minutes | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |
| Change from baseline in fat-free mass index at 8 weeks | Fat-free mass index (in kg/m²) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |
| Change from baseline in fat mass at 8 weeks | Fat mass (in %) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |
| Change from baseline in muscle mass at 8 weeks | Muscle mass (in %) will be estimated by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |
| Change from baseline in Bone Mineral Density at 8 weeks | Bone Mineral Density (BMD, in g/cm2) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer | From baseline to the end of treatment (8 weeks) in each study period (TRE and REG) |