[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417377":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":28,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Healthy control",null,"BMI of 18.5-29.9 kg\u002Fm2",{"label":13,"type":10,"description":14,"interventionNames":10},"Obese","BMI of 30-39.9 kg\u002Fm2",[16],{"name":17,"affiliation":18,"role":19},"Paule V Joseph, C.R.N.P.","National Institute on Alcohol Abuse and Alcoholism (NIAAA)","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Nada M Saleh","CONTACT","(301) 496-3799","nada.saleh@nih.gov",{"name":17,"role":23,"phone":10,"phoneExt":10,"email":27},"paule.joseph@nih.gov",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-77.10026,38.98067,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":47,"email":48},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY8664111010","prpl@cc.nih.gov",{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100417377","mechanisms-underlying-individual-variations-of-taste-and-smell-in-obesity-100417377",false,"NCT04714892","Mechanisms Underlying Individual Variations of Taste and Smell in Obesity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Males and females between 18 to 65 years of age. Due to documented knowledge that taste and smell changes with age, we will limit the cohort within this age range.\n* BMI between 18.5 and 29.9 kg\u002Fm\\^2 for healthy controls or between 30 and 39.9 kg\u002Fm\\^2 for obese subjects\n* Fasted plasma glucose levels between 68-126 mg\u002Fdl or per Clinical Center ranges, and hemoglobin A1C\\\u003C6.5%\n* Able to provide his\u002Fher own consent\n* Able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Because type-2 diabetic subjects have blunted taste responses, subjects with diagnosis of type II diabetes will be excluded.\n* Hypoglycemic drug intake.\n* Weight change of more than 15 pounds in the 6 months prior to screening\n* Positive pregnancy test, currently pregnant or breastfeeding.\n* Currently using any of the following medications: steroidal or nonsteroidal antiinflammatory medications, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, or antibiotics.\n* Received a diagnosis by a medical professional of morbid obesity, liver or renal disease.\n* Individuals with current heavy drinking. Women who drink 4 drinks or more in one occasion and 7 drinks in a week. Men who drink 5 drinks or more in one occasion and more than 14 drinks a week.\n* Use of tobacco products or illicit drugs (as determined by urine drug screen and\u002For history\u002Fphysical exam) in the last 30 days.\n* Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric).\n* Any self-reported history of chronic rhinitis, eating disorder (including binge eating), chronic upper respiratory infection, chronic allergic rhinitis, or nasal polyps in the last 6 months of screening, or current daily use of nasal sprays.\n* Abnormal complete blood count (CBC): White Blood Cell Count \\\u003C 4 or \\> 10 K\u002FuL, Red Blood Cell Count \\\u003C 4 or \\> 7 M\u002FuL, Hemoglobin \\\u003C 12 g\u002FdL for females or \\\u003C 13 g\u002FdL for males or any clinical signs\u002Fsymptoms that indicate iron deficiency anemia per clinician s judgment at screening \\[National Heart, Lung and Blood Institute (NHLBI) definition (Anemia - Iron-Deficiency Anemia, Diagnosis NHLBI, NIH)\\].\n* Bariatric surgery within the last 12 months of screening.\n* History of cancer (e.g., head and neck cancer) and\u002For history of cancer treatment (e.g., radiotherapy to the head and neck area or chemotherapy).\n* Altered cranial nerves identified by neurological evaluation during physical exam (screening visit).\n* Currently experiencing temporary change\u002Floss of taste and\u002For smell.\n* Persistent loss of taste and\u002For smell due to COVID-19 or other reasons.\n* Unable to read and understand English. Since all self-report measures are in English only, participants need to be able to read and understand the English language.\n* NIAAA employees\u002Fstaff or subordinates\u002Frelatives\u002Fco-workers of NIAAA employees\u002Fstaff or study investigators.",true,"ALL","18 Years","65 Years",{"count":62,"type":63},350,"ESTIMATED","OBSERVATIONAL","Background:\n\nChanges to the sense of taste or smell can change eating behavior. This may contribute to obesity. Researchers want to see how taste and smell perceptions that affect food choices may differ between people with obesity and without obesity.\n\nObjective:\n\nTo understand the role that senses of taste and smell play in food intake.\n\nEligibility:\n\nAdults ages 18-65 with obesity and without obesity\n\nDesign:\n\nParticipants will be screened with a medical history and physical exam. They will have a neurological and sensory exam. They will give blood and urine samples. They will be checked for previous SARS-CoV-2 infection. They will complete questionnaires about their eating habits, alcohol use, and smoking history.\n\nParticipants will have 2 study visits.\n\nParticipants will give stool, urine, blood, hair, nasal, and saliva samples. These samples will be used for gene testing.\n\nParticipants will have their weight, height, and hip and waist circumference measured. They will have an imaging scan that measures body composition.\n\nParticipants will complete questionnaires about their health, eating habits, and food preferences.\n\nParticipants will have taste tests and smell tests. They will have sensory tests to assess their response to stimuli.\n\nParticipants will have a dietary assessment. They will complete a food diary and a diet history questionnaire.\n\nParticipants will get a meal to eat. Data will be collected about their experience.\n\nParticipants will complete a sleep diary and wear a watch to measure their activity....",[67],"Obesity",[69,70,71,72,73,74],"chemosensation","Olfaction","Diet","obese","Perception","Natural History","2025-08-09",{"date":77,"type":78},"2025-08-12","ACTUAL",{"date":80,"type":78},"2022-05-11",{"date":82,"type":63},"2026-12-31",{"name":18,"class":6},1]