[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617855":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":101,"overallStatus":108,"whyStopped":30,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"King Saud University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Post-Bariatric Care","ACTIVE_COMPARATOR","Participants receive routine post-bariatric nutritional care with no prescribed meal-timing window. Dietitians provide standard guidance on protein adequacy (\\~60-80 g\u002Fday unless otherwise indicated), hydration, and routine micronutrient supplementation per clinic practice. Follow-ups occur at 3, 6, and 12 months; outcomes include body weight, metabolic markers, appetite-related hormones, questionnaires, wearables, and stool samples. This arm controls for the effects of usual care and non-timing dietary counseling.",[13],"Behavioral: Standard Post-Bariatric Care (Control)",{"label":15,"type":16,"description":17,"interventionNames":18},"Early Time-Restricted Eating (eTRE)","EXPERIMENTAL","Participants consume all caloric intake within a fixed daytime 10-hour window (08:00-18:00) on ≥6 days\u002Fweek. Water\u002Funsweetened tea\u002Fblack coffee are allowed outside the window. Diet composition follows bariatric guidelines (protein \\~60-80 g\u002Fday, hydration, routine micronutrients). Dietitians provide structured meal-timing plans and problem-solving support; timing logs and wearables document adherence. Assessments at 3, 6, and 12 months mirror the control arm.",[19],"Behavioral: Early Time-Restricted Eating (eTRE)",{"label":21,"type":16,"description":22,"interventionNames":23},"Chronotype-Based Chrono-Nutrition (CB-CN)","Meal timing is personalized to chronotype (morning\u002Fintermediate\u002Fevening) determined with the Munich Chronotype Questionnaire (MCTQ). Plans target an earlier first meal and completion of the last meal ≥3-4 h before habitual bedtime, with an eating window of \\~10 h\u002Fday on ≥6 days\u002Fweek, adjusted to chronotype using stepwise phase-advance strategies where needed. Diet composition follows bariatric guidelines (protein, hydration, micronutrients). Timing logs and wearables track adherence; visits at 3, 6, and 12 months.",[24],"Behavioral: Chronotype-Based Chrono-Nutrition (CB-CN)",[26,31,33],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Standard Post-Bariatric Care (Control)",[9],null,{"type":27,"name":15,"description":17,"armGroupLabels":32,"otherNames":30},[15],{"type":27,"name":21,"description":22,"armGroupLabels":34,"otherNames":30},[21],[36],{"name":37,"affiliation":5,"role":38},"Amani A Al-Farraj, Master","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Amani A Al-farraj, Master","CONTACT","+966508947215","Alfarrajamani@gmail.com",[46],{"facility":47,"status":30,"city":48,"state":30,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"King Saud Medical City","Riyadh","Saudi Arabia","SA",{"type":52,"coordinates":53},"Point",[54,55],46.72185,24.68773,{"lat":55,"lon":54},[58,60,62,64,67],{"name":59,"role":42,"phone":43,"phoneExt":30,"email":44},"Amani Alfarraj, Master",{"name":61,"role":38,"phone":30,"phoneExt":30,"email":30},"Amani Al-Farraj, Master",{"name":63,"role":38,"phone":30,"phoneExt":30,"email":30},"Alanoud Aladel, Phd",{"name":65,"role":66,"phone":30,"phoneExt":30,"email":30},"Mahmoud Abomeaty, Phd","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":30,"phoneExt":30,"email":30},"Raya Aldosary, Bachelor",{"type":38,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Amani Al-Farraj","Ms.",[73],{"name":47,"class":74},"OTHER_GOV","100617855","chrono-align-a-chronotype-based-chrono-nutrition-intervention-in-post-bariatric-patients-100617855",false,"NCT07324044","Chrono-ALIGN: A Chronotype-Based Chrono-Nutrition Intervention in Post-Bariatric Patients","Chrono-ALIGN Trial: The Impact of Chronotype-Based Chrono-Nutrition on Metabolic Health, Gut Microbiota, Appetite, and Circadian Alignment in Post-Bariatric Surgery Patients: A Randomized Controlled Trial","Chrono-ALIGN","Inclusion Criteria:\n\n* Adults aged 18-50 years who underwent Sleeve Gastrectomy (SG) 6 Months prior to enrollment.\n* Have achieved ≥50% of excess weight loss post-surgery (to ensure initial success).\n* Current BMI between 25-40 kg\u002Fm².\n* No major postoperative complications and cleared for a regular diet by their healthcare provider.\n* Participants must be able to align their eating schedule within a daytime window (morning to evening), ensuring that the first meal is consumed in the early part of the day and the last meal is completed before late evening, in accordance with chrono-nutrition guidelines.\n\nExclusion Criteria:\n\n* • Pregnancy or planned pregnancy during the study period, and post menopaused females\n\n  * Current diagnosis of severe psychiatric illness that may interfere with adherence (e.g., untreated major depression, psychosis, severe eating disorders).\n  * Active malignancy or serious chronic disease unrelated to obesity that may confound outcomes (e.g., advanced renal failure, uncontrolled liver disease).\n  * Use of medications known to significantly alter circadian rhythm or metabolism (e.g., corticosteroids, melatonin therapy) within the last 3 months.\n  * Inability to comply with study requirements (dietary interventions, sample collection, or follow-up visits).Participants who have previously undergone revision bariatric surgery.\n  * Individuals following intermittent fasting regimens prior to the study.",true,"ALL","18 Years","50 Years",{"count":88,"type":89},246,"ESTIMATED","INTERVENTIONAL",[92],"NA","This randomized controlled trial will evaluate the impact of chrono-nutrition, a dietary approach that aligns meal timing with the body's circadian rhythms, on weight change, metabolic outcomes, appetite, and gut microbiota in post-bariatric surgery patients. A total of 246 adults who underwent sleeve gastrectomy at least six months earlier will be enrolled at King Saud Medical City. Participants will be randomized to receive either standard post-bariatric nutritional care or personalized chrono-nutrition based on individual chronotype. Outcomes include weight change, metabolic biomarkers, dietary behaviors, sleep patterns, and gut microbiota composition. The study aims to determine whether integrating chrono-nutrition into post-bariatric follow-up can enhance metabolic health and improve long-term health.",[95,96,97,98,99,100],"Obesity (Disorder)","Morbid Obesity","Bariatric Sleeve Gastrectomy","Meal Time","Chronotype","Circadian Rhythm",[102,103,104,105,106,107],"chrononutrition","Bariatric Surgery","Gastric Sleeve","Gut Microbiota","Appetite","Meal Timing","NOT_YET_RECRUITING","2025-12-23",{"date":111,"type":112},"2026-01-07","ACTUAL",{"date":114,"type":89},"2026-01-01",{"date":116,"type":89},"2028-12-01",{"name":5,"class":6},1]