Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-28 @ 10:55 AM
Study NCT ID:
NCT05486702
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-Restricted Eating With Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in body composition on the dual-energy X-ray absorptiometry (DXA) at week 10', 'timeFrame': 'Baseline and Week 10', 'description': 'The DXA is a validated instrument, assessing fat, soft tissue, and bone mass.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if body composition differs between early time restricted eating (8-hour feeding period from 7 am to 3 pm) with exercise and late time restricted eating (8-hour feeding period from 3 pm to 11 pm) with exercise in overweight adults.', 'detailedDescription': 'Time-restricted eating (TRE) is a hot trend in weight-loss diets. TRE can reduce cardio-metabolic risks, thereby lowering body weight, blood pressure, lipid profile, glucose, and inflammation. The most effective way for the overweight population to improve body composition is to incorporate TRE with exercise. However, there were only two TRE interventions in humans that included exercise, suggesting that the additive effect of TRE to exercise may be dependent on dietary timing. TRE can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window. However, whether different TRE schedules with exercise can improve cardio-metabolic health is questionable. There have been no interventions of different TRE schedules with exercise. This study will be beneficial for determining which TRE schedule with exercise is efficacious to prevent cardio-metabolic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Lists of inclusion criteria: the participants will be allowed to participate in this study if they\n\n1. are adults, aged between 18-30 years\n2. are apparently healthy and physically inactive (defined as any form of physical activity performed \\< 2 days per week)\n3. are overweight (BMI 25-\\<30 kg/m2)\n4. are non-smokers\n5. are free from the following chronic medical conditions: heart disease, arrhythmias, diabetes, thyroid disease, bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorder, neuromuscular/neurological disease, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (HIV)\n6. are free from the orthopedic conditions that would hinder physical activity\n7. have not taken any heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinological (e.g, thyroid, insulin, etc), emotional/psychotropic (e.g,Prednisone, Ritalin, Adderall), neuromuscular/neurological, or androgenic medications(anabolic steroids)\n8. have low risk for cardiovascular disease and with no contraindications to exercise as outlined by the American College of Sports Medicine (ACSM) will be included.\n\nLists of exclusion criteria: the participants will not be allowed to participate in this study if they\n\n1. are younger than 18 years and older than 30 years.\n2. have consumed any medication for chronic medical condition.\n3. are participating in weight management programs.\n4. have constrictions to exercise.\n5. are currently exercising regularly (at least 2 days per week).'}, 'identificationModule': {'nctId': 'NCT05486702', 'acronym': 'TRE', 'briefTitle': 'Time-Restricted Eating With Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Georgia College and State University'}, 'officialTitle': 'The Effects of Different Time-Restricted Eating Schedules With Exercise on the Body Composition in Overweight Adults', 'orgStudyIdInfo': {'id': 'FRG202132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Time Restricted Eating', 'description': '8-hour eating period from 7 am to 3 pm with exercise', 'interventionNames': ['Other: Time Restricted Eating']}, {'type': 'EXPERIMENTAL', 'label': 'Late Time Restricted Eating', 'description': '8-hour eating period from 3 pm to 11 pm with exercise', 'interventionNames': ['Other: Time Restricted Eating']}], 'interventions': [{'name': 'Time Restricted Eating', 'type': 'OTHER', 'description': 'Time restricted eating (TRE) can be divided into early TRE (eTRE) and late TRE (lTRE), depending on the time of day of the eating window.', 'armGroupLabels': ['Early Time Restricted Eating', 'Late Time Restricted Eating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Milledgeville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jinkyung Park, Dr.', 'role': 'CONTACT', 'email': 'jinkyung.park@gcsu.edu', 'phone': '478-445-3930'}], 'facility': 'Exercise Science Laboratory', 'geoPoint': {'lat': 33.08014, 'lon': -83.2321}}, {'zip': '13244', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joon Young Kim, Dr.', 'role': 'CONTACT', 'email': 'jkim291@syr.edu', 'phone': '315-443-1411'}], 'facility': 'Clinical Research Laboratory', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '76308', 'city': 'Wichita Falls', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Soon-mi Choi, Dr.', 'role': 'CONTACT', 'email': 'soonmi.choi@msutexas.edu', 'phone': '940-397-4956'}], 'facility': 'Anatomical Laboratory', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}], 'centralContacts': [{'name': 'Jinkyung Park, Dr.', 'role': 'CONTACT', 'email': 'jinkyung.park@gcsu.edu', 'phone': '478-445-3930'}], 'overallOfficials': [{'name': 'Jinkyung Park, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia College and State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia College and State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jinkyung Park', 'investigatorAffiliation': 'Georgia College and State University'}}}}