[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586172":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":44,"locations":55,"responsibleParty":68,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Jordan","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"10-h Time restricted eating with caloric restriction","EXPERIMENTAL",null,[13],"Other: time restricted eating with caloric restriction",{"label":15,"type":16,"description":11,"interventionNames":17},"10-h time restricted eating without caloric restriction","ACTIVE_COMPARATOR",[18],"Other: time restricted eating without caloric restriction",{"label":20,"type":16,"description":11,"interventionNames":21},"caloric restriction without time restricted eating",[22],"Other: Caloric restriction without Time restricted eating",{"label":24,"type":16,"description":11,"interventionNames":25},"No time restricted eating - normal diet",[26],"Other: No time restricted eating - Normal diet",[28,32,36,40],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"time restricted eating with caloric restriction","will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value and fasted from 18:00 to 8:00 daily (a 14-h fast) in the 12-weeks intervention",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"time restricted eating without caloric restriction","will be asked to maintain their normal diet to the acceptable normal distribution ranges and fast from 8:00 to 18:00. They do not need to restrict caloric intake during the feeding window",[15],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Caloric restriction without Time restricted eating","will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value",[20],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"No time restricted eating - Normal diet","will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial",[24],[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Najd Abdullah Sarayreh, PhD","CONTACT","+962785556000","00962","najd.nutricenter@gmail.com",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Omar Mohammad Alkassasbeh, Master","00962785004201","kasasbeh@gmail.com",[56],{"facility":57,"status":11,"city":58,"state":11,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":11},"Najd Nutri Center","Amman","11110-17198","Jordan","JO",{"type":63,"coordinates":64},"Point",[65,66],35.94503,31.95522,{"lat":66,"lon":65},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Najd AlSarayreh","Principal investigator, PhD Candidate in Human Nutrition and Dietetics","100586172","the-effect-of-time-restricted-eating-on-glycemic-and-proinflammatory-biomarkers-among-prediabetic-obese-jordanian-adults-aged-18-40-years-old-100586172",false,"NCT06911918","The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old","The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Control Study","Inclusion Criteria:\n\n* IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score\n* female and male, BMI ≥ 30 to 39.9 kg\u002Fm2\n* age between 18 and 40 years\n* stable weight for 3 months before the beginning of the study\n* sedentary lifestyle\n\nExclusion Criteria:\n\n* previous weight loss surgery\n* pregnancy or intent to become pregnant\n* breastfeeding\n* chronic diseases\n* drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)\n* diabetic type 1 and 2 individuals\n* anyone physically active to reduce the influence of confounding covariates","ALL","18 Years","40 Years",{"count":83,"type":84},120,"ESTIMATED","INTERVENTIONAL",[87],"NA","Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks.\n\nParticipants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.",[90,91,92,93,94],"Insulin Resistance","Inflammation Biomarkers","Time Restricted Eating","Caloric Restriction","Obesity (Disorder)",[96,90,97,93,98],"Time restricted eating","Obesity","Inflammation cytokines","NOT_YET_RECRUITING","2025-03-27",{"date":102,"type":103},"2025-04-04","ACTUAL",{"date":105,"type":84},"2025-04-05",{"date":107,"type":84},"2025-11",{"name":5,"class":6},1]