[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329813":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":60,"studyPopulation":56,"armGroups":61,"interventions":78,"overallOfficials":56,"centralContacts":89,"locations":95,"responsibleParty":119,"collaborators":56,"id":123,"slug":56,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":56,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":56,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":98,"whyStopped":56,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Federal University of Minas Gerais","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Change in body weight","Body weight will be assessed by mechanical scale","Baseline and weeks 2, 4 and 8",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Change in body composition","Body composition will be assessed by electrical bioimpedance",{"measure":18,"description":19,"timeFrame":12},"Change in resting energy expenditure","Resting energy expenditure will be assessed by indirect calorimetry",{"measure":21,"description":22,"timeFrame":12},"Change in self-reported energy intake","Dietary energy intake will be assessed with 3-days food records",{"measure":24,"description":25,"timeFrame":12},"Change in self-reported diet composition","Dietary macronutrient intake will be assessed with 3-days food records",{"measure":27,"description":28,"timeFrame":12},"Change in self-reported intervention adherence","Adherence will be assessed by daily record of feeding hours",{"measure":30,"description":31,"timeFrame":12},"Change in metabolic profile","Fasting lipids, glucose and free fatty acids",{"measure":33,"description":34,"timeFrame":12},"Change in self-reported stress","Self-reported stress will be assessed by a questionnaire (Perceived Stress Scale). The total of the scale is a sum of scores of 14 questions. Total score can range from zero to 56. The higher the score, the higher the level of stress.",{"measure":36,"description":37,"timeFrame":12},"Change in self-reported anxiety","Self-reported anxiety will be assessed by a questionnaire (Beck Anxiety Inventory). The questionnaire consists of 21 items and the severity of each of them scored from 0 to 3. The degree of anxiety will be classified according to the final score obtained: 0-7 absent or minimum; 8-15 light; 16-25 moderate; 26-63 severe.",{"measure":39,"description":40,"timeFrame":12},"Change in self-reported depression","Self-reported depression will be assessed by a questionnaire (Beck Depression Inventory). The questionnaire consists of 21 items and the severity of each one scored from 0 to 3. The volunteers will be classified according to the score obtained: BDI ≤ 15: without depression; 16 ≤ BDI ≤ 20: dysphoria; BDI\\> 20: depression.",[42,45,47,49,51],{"measure":43,"description":44,"timeFrame":12},"High-sensitivity C-reactive protein","Change will be assessed in blood sample",{"measure":46,"description":44,"timeFrame":12},"Insulin",{"measure":48,"description":44,"timeFrame":12},"Leptin",{"measure":50,"description":44,"timeFrame":12},"Ghrelin",{"measure":52,"description":44,"timeFrame":12},"Brain-Derived Neurotrophic Factor (BDNF)",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":56,"timePerspective":56,"maskingInfo":58},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":59,"maskingDescription":56,"whoMasked":56},"NONE","The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.",[62,68,74],{"label":63,"type":64,"description":65,"interventionNames":66},"Caloric restriction only","ACTIVE_COMPARATOR","Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.",[67],"Behavioral: Caloric restriction only",{"label":69,"type":70,"description":71,"interventionNames":72},"Caloric restriction plus TRF morning","EXPERIMENTAL","Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.",[73],"Behavioral: Caloric restriction plus TRF morning",{"label":75,"type":70,"description":71,"interventionNames":76},"Caloric restriction plus TRF night",[77],"Behavioral: Caloric restriction plus TRF night",[79,83,86],{"type":80,"name":63,"description":81,"armGroupLabels":82,"otherNames":56},"BEHAVIORAL","Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks.",[63],{"type":80,"name":69,"description":84,"armGroupLabels":85,"otherNames":56},"Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks.",[69],{"type":80,"name":75,"description":87,"armGroupLabels":88,"otherNames":56},"Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks.",[75],[90],{"name":91,"role":92,"phone":93,"phoneExt":56,"email":94},"Adaliene VM Ferreira, PhD","CONTACT","+553134093680","adaliene@gmail.com",[96,112],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Hospital da Clínicas","RECRUITING","Belo Horizonte","Minas Gerais","30130-100","Brazil","BR",{"type":105,"coordinates":106},"Point",[107,108],-43.93778,-19.92083,{"lat":108,"lon":107},[111],{"name":91,"role":92,"phone":93,"phoneExt":56,"email":94},{"facility":113,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Hospital das Clínicas",{"type":105,"coordinates":115},[107,108],{"lat":108,"lon":107},[118],{"name":91,"role":92,"phone":93,"phoneExt":56,"email":94},{"type":120,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Adaliene Versiani M. Ferreira","PhD","100329813",false,"NCT03574103","Chronic Effect of Fasting","Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity","Inclusion Criteria:\n\n* Females;\n* Aged between 18 and 59 years old;\n* Body mass index equal or greater 25 kg\u002Fm²;\n* Agree to sign the informed consent.\n\nExclusion Criteria:\n\n* Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);\n* Thyroid diseases or medications for its treatment;\n* Medications known to affect total energy expenditure;\n* Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and\u002For inflammatory parameters;\n* Previous surgery for weight loss;\n* Pregnancy or breast-feeding;\n* Smoking;\n* Alcohol use (\\>2 doses\u002Fday).",true,"FEMALE","18 Years","59 Years",{"count":134,"type":135},45,"ESTIMATED","INTERVENTIONAL",[138],"NA","The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.",[141],"Overweight and Obesity",[143,144,145,146],"Obesity","Overweight","Weight loss","Fasting","2025-03-14",{"date":149,"type":150},"2025-03-18","ACTUAL",{"date":152,"type":150},"2018-07-09",{"date":154,"type":135},"2026-12",{"name":5,"class":6},2]