[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481154":3},{"organization":4,"armGroups":7,"interventions":56,"overallOfficials":87,"centralContacts":92,"locations":101,"responsibleParty":120,"collaborators":62,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":62,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":62,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":104,"whyStopped":62,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,20,24,28,32,36,40,44,48,52],{"label":9,"type":10,"description":11,"interventionNames":12},"Set 1","ACTIVE_COMPARATOR","+150% LPF +150% SOF -50% +200% LPF +200% SOF Fasting -25%",[13,14,15,16,17,18,19],"Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","Dietary Supplement: fasting","Dietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat","Dietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","Dietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein","Dietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","Dietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein",{"label":21,"type":10,"description":22,"interventionNames":23},"Set 10","+200% LPF -25% Fasting +200% SOF -50% +150% LPF +150% SOF",[13,14,15,16,17,18,19],{"label":25,"type":10,"description":26,"interventionNames":27},"Set 2","+150% LPF +200% LPF -50% +150% SOF Fasting -25% +200% SOF",[13,14,15,16,17,18,19],{"label":29,"type":10,"description":30,"interventionNames":31},"Set 3","+150% LPF Fasting +150% SOF -25% +200% SOF +200% LPF -50%",[13,14,15,16,17,18,19],{"label":33,"type":10,"description":34,"interventionNames":35},"Set 4","Fasting -25% +200% LPF -50% +200% SOF +150% SOF +150% LPF",[13,14,15,16,17,18,19],{"label":37,"type":10,"description":38,"interventionNames":39},"Set 5","-25% +150% SOF +200% LPF +150% LPF Fasting +200% SOF -50%",[13,14,15,16,17,18,19],{"label":41,"type":10,"description":42,"interventionNames":43},"Set 6","Fasting +200% LPF +200% SOF -50% +150% LPF -25% +150% SOF",[13,14,15,16,17,18,19],{"label":45,"type":10,"description":46,"interventionNames":47},"Set 7","-50% +200% SOF -25% +150% SOF Fasting +200% LPF +150% LPF",[13,14,15,16,17,18,19],{"label":49,"type":10,"description":50,"interventionNames":51},"Set 8","-50% +150% SOF +200% SOF +150% LPF -25% +200% LPF Fasting",[13,14,15,16,17,18,19],{"label":53,"type":10,"description":54,"interventionNames":55},"Set 9","+150% SOF -25% +150% LPF +200% SOF Fasting +200% LPF -50%",[13,14,15,16,17,18,19],[57,63,67,71,75,79,83],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DIETARY_SUPPLEMENT","+200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","+200% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat",[9,21,25,29,33,37,41,45,49,53],null,{"type":58,"name":64,"description":65,"armGroupLabels":66,"otherNames":62},"fasting","Fasting for at least 24 hours",[9,21,25,29,33,37,41,45,49,53],{"type":58,"name":68,"description":69,"armGroupLabels":70,"otherNames":62},"-50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat","-50% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat",[9,21,25,29,33,37,41,45,49,53],{"type":58,"name":72,"description":73,"armGroupLabels":74,"otherNames":62},"+150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","+150% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat",[9,21,25,29,33,37,41,45,49,53],{"type":58,"name":76,"description":77,"armGroupLabels":78,"otherNames":62},"+200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein","+200% of energy balance requirements with low protein macronutrient balance of 51% of the calories from carbohydrates, 46%, from fat and 3% from protein.",[9,21,25,29,33,37,41,45,49,53],{"type":58,"name":80,"description":81,"armGroupLabels":82,"otherNames":62},"-25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat","-25% of energy balance (EB) requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat",[9,21,25,29,33,37,41,45,49,53],{"type":58,"name":84,"description":85,"armGroupLabels":86,"otherNames":62},"+150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein","+150% of energy balance requirements with low protein macronutrient balance of 51% of the calories from carbohydrates, 46%, from fat and 3% from protein.",[9,21,25,29,33,37,41,45,49,53],[88],{"name":89,"affiliation":90,"role":91},"Tomas Cabeza De Baca, Ph.D.","National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","PRINCIPAL_INVESTIGATOR",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":62,"email":97},"Office of Participant Recruitment (NIDDK","CONTACT","(602) 200-5315","niddkphxcontact@mail.nih.gov",{"name":89,"role":95,"phone":99,"phoneExt":62,"email":100},"(301) 496-9404","tommy.cabezadebaca@nih.gov",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"NIDDK, Phoenix","RECRUITING","Phoenix","Arizona","85004","United States","US",{"type":111,"coordinates":112},"Point",[113,114],-112.07404,33.44838,{"lat":114,"lon":113},[117],{"name":118,"role":95,"phone":119,"phoneExt":62,"email":97},"Office of Participant Recruitment-NIDDK","602-200-5315",{"type":121,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100481154","the-effects-of-increasing-caloric-intake-on-diet-induced-thermogenesis-and-24h-energy-expenditure-100481154",false,"NCT05545306","The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Male or female, aged 18-60 years old\n* No episodes of intentional weight loss over previous 6 months\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Current use of tobacco products that exceed \"Very Low Dependence\" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2)\n* Diabetes\n\n  i. Fasting glucose \\>= 126 mg\u002Fdl or hba1c \\>= 6.5% or\n\nii. history of type 1 or type 2 diabetes\n\n-Endocrine disorders, such as\n\ni. History of Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism\n\nii. TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL\n\n* Pulmonary disorders\n\n  i. History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)\n* Cardiovascular diseases,\n\n  i. Including history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease\n* Hypertension,\n\n  i. History of diagnosis and current treatment by an outside clinician\n\nii. or sitting blood pressure measurement, using an appropriate cuff, higher than\n\n140\u002F90 mmHg\n\n-Liver disease,\n\ni. including history of cirrhosis, active hepatitis B or C\n\nii. AST or ALT \\>=3 times upper limit of normal on screening labs\n\n* Renal disease\n\n  i. Serum creatinine \\>= 1.5 mg\u002Fdls\n* Abnormal kidney function (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2)\n* Central nervous system disease:\n\n  i. including history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders\n* Cancer:\n\n  i. History requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer).\n* Infectious disease:\n\n  i. History of active tuberculosis, HIV chronic coccidiomycosis or other chronic infections\n* Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators\n* Evidence of alcohol abuse as defined by \\> =8-point score on the Alcohol consumption screening AUDIT questionnaire in adults\n* Current use of illegal drugs such as amphetamines, cocaine, opiates, or heroin; use of marijuana is permitted.\n* For Females:\n\n  * i. Pregnancy or lactation by history and urine pregnancy test\n  * ii. Peri- or post-menopause by self-report or irregular menstrual cycle.\n* Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer).\n* Inability to speak or read English by self-report.\n* Inability to provide informed consent\n* History of psychological conditions including (but not limited to) claustrophobia, clinical depression, bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study\n* Current use of medications\u002Fdietary supplements\u002Falternative therapies known to alter energy metabolism\n* Inability to consume provided diets due to dietary concerns that will not allow them to consume \\>=95% of provided calories.",true,"ALL","18 Years","60 Years",{"count":133,"type":134},120,"ESTIMATED","INTERVENTIONAL",[137],"NA","Background:\n\nDiet-induced thermogenesis (DIT) is the amount of energy one's body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT.\n\nObjective:\n\nTo learn how different diets can change a person's DIT.\n\nEligibility:\n\nHealthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months.\n\nDesign:\n\nParticipants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets.\n\nParticipants will undergo multiple tests.\n\nThey will be screened with blood and urine tests and a test of their heart function.\n\nDuring the first few days:\n\nTheir waist, thigh, and neck circumference will be measured.\n\nThey will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body.\n\nThey will be tested for diabetes.\n\nThey will answer questionnaires about topics including eating behavior, hunger, and stress.\n\nThroughout the study:\n\nTheir weight will be measured daily.\n\nBlood tests will be repeated.\n\nThey will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period.\n\n...",[140,141,142],"Obesity","Normal Physiology","Healthy Volunteers",[144,145,146,147,148],"Weight Gain","Energy Expenditure","Low Protein Overfeeding","Fasting","Natural History","2026-06-10",{"date":151,"type":152},"2026-06-11","ACTUAL",{"date":154,"type":152},"2023-06-06",{"date":156,"type":134},"2027-02-02",{"name":90,"class":6},1]