Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:29 AM
Study NCT ID:
NCT07451132
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-restricted Eating and Circadian Health in Night Shift Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in body mass index at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': '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.'}, {'measure': 'Change from baseline in fat mass index at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Fat mass index (in kg/m²) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer'}, {'measure': 'Change from Baseline in sleep duration at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Sleep duration will be measured through continuous actigraphic recordings during daytime and nighttime for 10 days, and expressed in minutes'}, {'measure': 'Change from baseline in fat-free mass index at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Fat-free mass index (in kg/m²) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer'}, {'measure': 'Change from baseline in fat mass at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Fat mass (in %) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer'}, {'measure': 'Change from baseline in muscle mass at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Muscle mass (in %) will be estimated by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer'}, {'measure': 'Change from baseline in Bone Mineral Density at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Bone Mineral Density (BMD, in g/cm2) will be assessed by dual-energy X-ray absorptiometry (DXA) using a Lunar DPXL densitometer'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in the mean fasting glycemia at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)', 'description': 'Fasting glycemia level (in mg/dL) will be measured from fasting blood samples and measured with the hexokinase method'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to end of treatment (8weeks) in 24-h glycemic control', 'timeFrame': 'From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)', 'description': '24-h glycemic control (expressed in mg/dL), measured with continuous glucose monitoring (CGM) using a portable capillary glucose sensor, over 10 consecutive days.'}, {'measure': '24-hour motor activity level (counts/min)', 'timeFrame': 'From enrollment to the end of treatment (at 8 weeks), in each study period (TRE and REG)', 'description': 'Motor activity will be assessed by accelerometric recordings (actigraphic data) of wrist activity. Actigraphy data will assess motor activity before and after the intervention'}, {'measure': 'Change from Baseline in the circadian clock-genes expression at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)', 'description': '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.'}, {'measure': 'Change from baseline in thiobarbituric acid reactive substances (TBARS) level at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)]', 'description': 'TBARS level (in µM/ml) will be measured in plasma samples'}, {'measure': 'Change from baseline in F-8 isoprostane level at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'F-8 isoprostane level (in pg/mL) will be measured in plasma samples'}, {'measure': 'Change from Baseline in Appetite-related feelings at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': '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).'}, {'measure': 'Change from baseline in total-, reduced- and oxidized glutathione levels at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Total-, reduced-, and oxidized glutathione levels (in µM) will be measured in plasma samples'}, {'measure': 'Change from baseline in C-reactive protein levels at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'C-reactive protein levels (in mg/L) will be measured in serum samples'}, {'measure': 'Change from baseline in pro-inflammatory cytokine levels at 8 weeks', 'timeFrame': 'From baseline to the end of treatment (8 weeks) in each study period (TRE and REG)', 'description': 'Interleukin 1β, Interleukin 6, and Tumor necrosis factor (TNF-α) levels (in pg/mL) will be measured in plasma samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['time-restricted eating', 'shiftwork', 'intermittent fasting'], 'conditions': ['the Study Focuses on Time-restricted Eating in Healthcare Shiftworkers']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (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\n\nExclusion Criteria:\n\n* Current and chronic neurological disorders\n* Pathologies related to abnormal adrenal activity\n* Liver or kidney disease\n* Uncontrolled hypertension, dyslipidemia, and thyroid disease\n* Insulin resistance and T2D\n* BMI ≥40 kg/m2\n* Use of medications known to alter body composition, such as insulin sensitizers, glucocorticoids, or anti-depressants\n* Autoimmune diseases with acute symptoms; recent surgery of any kind (in the last 3 months);\n* Acute, chronic inflammation (usCRP \\>10 mg/L)\n* Following any dietary restriction (special diet) in the previous three months\n* Having a short sleep (habitual sleep duration of less than 6h per day)\n* History of bariatric surgery\n* Depression (Beck Depression Inventory) or sleep disorders (Pittsburgh Sleep Questionnaire)\n* Night-eating syndrome (Night Eating Questionnaire)\n* Intense exercise level (\\>3 days/week of high-intensity exercise)\n* Having traveled across time zones (at any time during the last month) and planning travel during the study\n* Pregnant or intend to become pregnant, and\n* Lactating women'}, 'identificationModule': {'nctId': 'NCT07451132', 'acronym': 'FastingClocks', 'briefTitle': 'Time-restricted Eating and Circadian Health in Night Shift Workers', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Effect of a Time-restricted Eating Protocol on Glucose Homeostasis, Markers of Circadian System, Appetite Control, and Oxidative Stress Parameters in Night Shift Workers', 'orgStudyIdInfo': {'id': 'TRE-Shift-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-restricted eating', 'description': '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).', 'interventionNames': ['Behavioral: Time-restricted eating']}, {'type': 'NO_INTERVENTION', 'label': 'Regular eating', 'description': 'Participants must maintain their usual eating pattern (i.e., usual eating window) for 8 weeks, but without any dietary or lifestyle changes'}], 'interventions': [{'name': 'Time-restricted eating', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Time-restricted eating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380453', 'city': 'Santiago', 'state': 'Metropolitan Region', 'country': 'Chile', 'facility': 'Faculty of Medicine, University of Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Lucía Cifuentes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ethics Committee for Human Subjects of the Faculty of Medicine, University of Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Published data generated from the study will be available from the leading author, upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agencia Nacional de Investigacion y Desarrollo, ANID', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Rodrigo Chamorro', 'investigatorAffiliation': 'University of Chile'}}}}