Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-09 @ 10:45 AM
Study NCT ID:
NCT03745612
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight over 12 months', 'timeFrame': 'Baseline to 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in body composition', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in liver fat', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in visceral fat', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in Blood pressure', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in blood lipids', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in β cell function', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Change in pulse wave velocity (PWV)', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Depression measured by the Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)', 'timeFrame': 'Baseline to 12 months'}, {'measure': 'Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)', 'timeFrame': 'Baseline to 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Time Restricted Feeding', 'Weight Loss', 'Calorie Restriction']}, 'referencesModule': {'references': [{'pmid': '35443107', 'type': 'RESULT', 'citation': 'Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.'}]}, 'descriptionModule': {'briefSummary': 'Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months compared to continuous energy restriction (CER).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male of female aged between 18 and 75 years old;\n2. Body mass index (BMI)of 28.0 to 45.0 kg/m2;\n\nExclusion Criteria:\n\n1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;\n2. Diagnosis of type 1 and type 2 diabetes;\n3. History of malignant tumors;\n4. Serious liver dysfunction or chronic kidney disease (AST or ALT \\> 3 times the upper limit of normal, or eGFR\\<30 ml/min/1.73 m2);\n5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;\n6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;\n7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;\n8. Being a smoker or having been a smoker in the 3 months prior to their screening visit;\n9. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;\n10. Currently participating in weight loss programs or weight change in the past 3 months (\\> 5% current body weight) ;\n11. Women who are pregnant or plan to become pregnant;\n12. Patients who cannot be followed for 24 months (due to a health situation or migration);\n13. Patients who are unwilling or unable to give informed consent."}, 'identificationModule': {'nctId': 'NCT03745612', 'acronym': 'TREATY', 'briefTitle': 'Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'NFEC-2018-145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRF', 'description': 'Time restricted feeding', 'interventionNames': ['Behavioral: Time restricted feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CER', 'description': 'continuous energy restriction', 'interventionNames': ['Behavioral: Continuous Energy Restriction']}], 'interventions': [{'name': 'Time restricted feeding', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).', 'armGroupLabels': ['TRF']}, {'name': 'Continuous Energy Restriction', 'type': 'BEHAVIORAL', 'description': 'Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.', 'armGroupLabels': ['CER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Huijie Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}