protocolSection identificationModule nctId: NCT06271200, orgStudyIdInfo id: MG-113-GP-03, briefTitle: Intervention on Metabolism and Related Chronic Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: National Health Research Institutes, Taiwan, class: OTHER, collaborators name: Tri-Service General Hospital, collaborators name: Chang Gung Memorial Hospital, collaborators name: National Taiwan University Hospital Hsin-Chu Branch, collaborators name: Taichung Armed Forces General Hospital, descriptionModule briefSummary: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks., conditionsModule conditions: Metabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting and 10,000 steps per day, outcomesModule primaryOutcomes measure: Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes, city: Zhunan, state: Miaoli County, zip: 350, country: Taiwan, contacts name: Vivian Wang, Master, role: CONTACT, phone: +886-37-206166, phoneExt: 35374, email: ywwang@nhri.edu.tw, geoPoint lat: 22.57358, lon: 120.54147, hasResults: False