Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-28 @ 11:58 PM
Study NCT ID:
NCT05795205
Status:
UNKNOWN
Last Update Posted:
2023-04-07
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delayed Dinner, Exercise and Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic health (Oral glucose tolerance test, OGTT)', 'timeFrame': '120 minutes', 'description': 'Fasting and postprandial blood glucose responses on next morning between trials'}, {'measure': 'Metabolic health (Oral glucose tolerance test, OGTT)', 'timeFrame': '120 minutes', 'description': 'Fasting and postprandial blood insulin responses on next morning between trials'}], 'secondaryOutcomes': [{'measure': 'Inflammation', 'timeFrame': 'Baseline', 'description': 'Fasting inflammatory biomarkers (IL-6, TNF-a, CRP) on next morning between trials'}, {'measure': 'Visual analogue scale (VSA)', 'timeFrame': '120 minutes', 'description': 'Changes in VAS from 0-100 mm (e.g., appetite \\& mood, etc.) on next morning between trials'}, {'measure': 'Substate oxidation', 'timeFrame': '120 minutes', 'description': 'Lipid and carbohydrate oxidation during OGTT between trials'}, {'measure': 'Blood pressure', 'timeFrame': '120 minutes', 'description': 'Changes in blood pressure (systolic and diastolic blood pressure) on next morning between trials'}, {'measure': 'Appetite (lunch intake)', 'timeFrame': '30 minutes', 'description': 'Ab libitum energy intake on next morning by the end of trial'}, {'measure': 'HRV', 'timeFrame': 'Baseline', 'description': 'Heart rate variability on next morning between trial'}, {'measure': 'Gut hormones', 'timeFrame': '120 minutes', 'description': 'Changes in blood gut hormones responses on next morning (e.g., GLP-1, PYY and GIP) between trials'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['late dinner', 'postprandial Glycaemia'], 'conditions': ['Normal Dinner', 'Delayed Dinner', 'Exercise Plus Delayed Dinner']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical inactive males\n* Weight stable for more than 3 months (no change in weight +/- 3%)\n* Non-smoker\n* Able to walk comfortably on a treadmill\n* Dinner consumers with normal sleep pattern (cycles)\n\nExclusion Criteria:\n\n* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia\n* Taking medications that may influence lipid or carbohydrate metabolism or immune system function\n* Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)'}, 'identificationModule': {'nctId': 'NCT05795205', 'briefTitle': 'Delayed Dinner, Exercise and Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'Impact of Exercise on Metabolic Health Following Delayed Dinner Consumption in Healthy Adults', 'orgStudyIdInfo': {'id': '202203HM008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal dinner consumption', 'description': 'Participants will have their dinner between 1800-1830pm', 'interventionNames': ['Behavioral: Normal dinner']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed dinner consumption', 'description': 'Participants will have their dinner between 2200-2230pm', 'interventionNames': ['Behavioral: Delayed dinner consumption']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise with delayed dinner consumption', 'description': 'Participants will exercise on a treadmill for 45 min followed by delayed dinner between 2200-2230pm', 'interventionNames': ['Behavioral: Exercise with delayed dinner consumption']}], 'interventions': [{'name': 'Normal dinner', 'type': 'BEHAVIORAL', 'description': 'Participants will consume breakfast at 0830-0855 am, lunch at 1230-1255 pm, followed by dinner at 1800-1825 pm. Snacks will be consumed at 2130-2140 pm.', 'armGroupLabels': ['Normal dinner consumption']}, {'name': 'Delayed dinner consumption', 'type': 'BEHAVIORAL', 'description': 'Participants will consume breakfast at 08:30-08:55 am, lunch at 12:30-12:55 pm, followed by snacks at 18:00-18:10 pm. Dinner will be consumed at 21:30-21:55 pm.', 'armGroupLabels': ['Delayed dinner consumption']}, {'name': 'Exercise with delayed dinner consumption', 'type': 'BEHAVIORAL', 'description': 'Participants will consume breakfast at 08:30-08:55 am, lunch at 12:30-12:55 pm, followed by snacks at 18:00-18:10 pm. Participants will exercise for 45 min at moderate-intensity 45 min prior to the delayed dinner at 21:30-21:55 pm.', 'armGroupLabels': ['Exercise with delayed dinner consumption']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yung-Chih Chen, PhD', 'role': 'CONTACT', 'email': 'yc.chen@ntnu.edu.tw'}], 'facility': 'National Taiwan Normal University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yung-Chih Chen', 'role': 'CONTACT', 'email': 'yc.chen@ntnu.edu.tw', 'phone': '+886277496979'}, {'name': 'Chen', 'role': 'CONTACT', 'email': 'yc.chen@ntnu.edu.tw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yung-Chih Chen', 'investigatorAffiliation': 'National Taiwan Normal University'}}}}