Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT04618133
Status:
COMPLETED
Last Update Posted:
2024-12-16
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time-restricted Eating in Morning Chronotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in in vitro circadian parameters (amplitude and magnitude)', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured in cultured skin fibroblasts (in a subset of the study population)'}, {'measure': 'Change in metabolomic parameters', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by high-throughput mass spectrometry metabolomics'}, {'measure': 'Change in lipid metabolism', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by high-throughput mass spectrometry lipidomics'}, {'measure': 'Change in blood hormonal profile', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Cortisol, insulin, thyroid-stimulating hormone'}], 'primaryOutcomes': [{'measure': 'Change in body fat mass', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by dual-energy x-rax absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Change in physical activity', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by actigraphy'}, {'measure': 'Change in sleep/wake cycles', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by actigraphy'}, {'measure': 'Change in ambient light', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by actigraphy'}, {'measure': 'Change in sleep quality', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by the Pittsburgh Sleep Quality Index (scale 0-21, 0 indicating no sleeping difficulty, 21 indicating severe sleeping difficulties)'}, {'measure': 'Change in eating duration', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Duration from the first to last caloric intake over 24-hour cycle'}, {'measure': 'Change in calorie intake over the 24-hour cycle', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Assessed by a 24-hour food recall'}, {'measure': 'Change in weight', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Body weight (kg)'}, {'measure': 'Change in waist circumference', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Waist circumference (cm) assessed with a measuring tape'}, {'measure': 'Change in hip circumference', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Hip circumference (cm) assessed with a measuring tape'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured with an arm cuff in the sitting position'}, {'measure': 'Change in fasting glucose', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured in clinical chemistry'}, {'measure': 'Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by clinical chemistry'}, {'measure': 'Change in body fat mass', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by bioelectrical impedance analysis (BIA)'}, {'measure': 'Change in lean body mass', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by dual-energy x-rax absorptiometry (DXA)'}, {'measure': 'Change in fat-free mass', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by bioelectrical impedance analysis (BIA)'}, {'measure': 'Change in resting energy expenditure', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by indirect calorimetry'}, {'measure': 'Change in glucose excursion', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'As measured by continuous glucose monitoring'}, {'measure': 'Incidence of adverse events in response to the randomized intervention', 'timeFrame': 'From randomization visit to close-out visit (12 weeks)', 'description': 'Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Overweight and obesity are highly prevalent conditions worldwide, despite active research of new interventions over decades. Current interventions include medications or bariatric surgery, but these approaches cannot be used in all patients and require clear indications and a close multidisciplinary management. Therefore most patients and physicians rely on lifestyle interventions, focusing on a balanced diet and physical exercise.\n\nRecent studies have uncovered that energy metabolism is also regulated by circadian rhythms, which depend on spontaneous diurnal oscillations of the central clock, retinal sensing of ambient light, and daily feeding-fasting cycles. The chronotype has an influence on behavioral patterns, where some people describe that they are more alert in the morning or in the evening: The morning or evening chronotypes, respectively. However, in modern societies, many people are exposed to external cues in misalignment with their circadians clocks. The mismatch between the individual chronotype and the social/work life can lead to metabolic disorders.\n\nTime-restricted eating (TRE), i.e. energy intake limited to certain windows of time without restricting calories, is an appealing approach because it proposes to realign the circadian clocks with external cues provided by the timing of food intake, thus leading to better metabolic outcomes.\n\nThe investigators speculate that the TRE intervention needs to be personalized to reach efficacy in a broader population. To tailor the TRE intervention to each individual and harmonize their eating patterns in accordance to their chronotype, the investigators plan to test early TRE vs. late TRE vs. active control in overweight and obese individuals with morning chronotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical criteria\n\n * Men and premenopausal women\n * Age 25-50 years\n * BMI 25-34 kg/m2\n * Stable weight (maximum ± 2 kg of usual body weight) over the previous 3 months\n * Stable body fat mass (maximum ± 1 kg of body fat mass) during the run-in phase\n * Eating window ≥ 12 hours during the run-in phase\n * Morning chronotype\n* Work-related criteria\n\n * Daytime work at least 3 days per week over the previous 1 month and planned during the study\n* Study-related criteria\n\n * Able to give informed consent and follow the study procedures for the entire duration\n * Confident use of a smartphone and able to take regular pictures of food/drinks\n\nExclusion Criteria:\n\n* Clinical criteria\n\n * Pregnant and breastfeeding women, plans for maternity during the study\n * On a diet, intermittent fasting, in a weight management program over the previous 3 months or planned during the study\n * Eating disorder(s) or prior bariatric surgery\n * Diabetes with hypoglycemic drug(s)\n * Major illness/fever over the previous 1 month\n * Active major cardiovascular, respiratory, liver, gastrointestinal, renal, neurological or endocrine disorders\n * Coagulation disorder, on anticoagulant drug, skin disorder affecting wound healing\n * Active cancer and/or oncologic treatment over the previous 12 months\n * Major sleep disorder (including untreated sleep apnea syndrome), major mental illness\n * Consumption of \\> 7 standard units of alcohol per week for women and \\> 14 standard units of alcohol per week for men\n* Work and time-related criteria\n\n * Shift work, such as evening shifts or night shifts, over the previous 1 month or planned during the study\n * Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 1 month or planned during the study\n* Study-related criteria and other interventions\n\n * Enrolled in another interventional clinical trial (medication, medical device) over the previous 1 month and planned during the study\n * Regular medications over the previous 1 month that could affect the study endpoints (e.g. centrally acting, medications affecting gut absorption, transit or weight, hypoglycemic drug, hormonal treatment...)'}, 'identificationModule': {'nctId': 'NCT04618133', 'briefTitle': 'Time-restricted Eating in Morning Chronotype', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Time-restricted Eating to Improve Body Fat Mass in Overweight and Obese Individuals with Morning Chronotype: a Randomized, Open-label, Multi-arm Trial', 'orgStudyIdInfo': {'id': '2020-01439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early time-restricted eating', 'description': 'Duration: 12 weeks', 'interventionNames': ['Behavioral: Early time-restricted eating']}, {'type': 'EXPERIMENTAL', 'label': 'Late time-restricted eating', 'description': 'Duration: 12 weeks', 'interventionNames': ['Behavioral: Late time-restricted eating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control', 'description': 'Duration: 12 weeks', 'interventionNames': ['Behavioral: Active control']}], 'interventions': [{'name': 'Early time-restricted eating', 'type': 'BEHAVIORAL', 'otherNames': ['Early TRE'], 'description': 'Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from 6am to 2pm, with a 1-hour allowance according to their daily routine', 'armGroupLabels': ['Early time-restricted eating']}, {'name': 'Late time-restricted eating', 'type': 'BEHAVIORAL', 'otherNames': ['Late TRE'], 'description': 'Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from noon to 8pm, with a 1-hour allowance according to their daily routine', 'armGroupLabels': ['Late time-restricted eating']}, {'name': 'Active control', 'type': 'BEHAVIORAL', 'description': 'Participants will be advised to eat a minimum of 3 meals over the 24-hour cycle, i.e. breakfast from 6am to 9am, lunch from 11am to 2pm, dinner from 6pm to 10pm. Snacks will be allowed between meals', 'armGroupLabels': ['Active control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Tinh-Hai Collet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geneva University Hospitals, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tinh-Hai Collet, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tinh-Hai Collet, MD', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}