[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596966":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":61,"collaborators":24,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Miami","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-load Condition Meal Group","EXPERIMENTAL","Participants will be in this group for up to 2 weeks.",[13,14],"Other: Preload condition","Other: Ad-libitum control condition",{"label":16,"type":17,"description":11,"interventionNames":18},"Ad-libitum Condition Meal Group","ACTIVE_COMPARATOR",[14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Preload condition","Participants will consume a fixed compulsory preload meal of Campbell's Tomato soup (\\~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (\\~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load condition visit will be up to 6 hours",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Ad-libitum control condition","Participants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (\\~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours.",[16,9],[30],{"name":31,"affiliation":5,"role":32},"Gary J Farkas, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Guillermo Mederos","CONTACT","305-243-4518","gxm1228@med.miami.edu",{"name":31,"role":36,"phone":37,"phoneExt":24,"email":40},"gjf50@med.miami.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Miami - Miami Project to Cure Paralysis","RECRUITING","Miami","Florida","33136","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-80.19366,25.77427,{"lat":54,"lon":53},[57,58,60],{"name":31,"role":36,"phone":37,"phoneExt":24,"email":40},{"name":35,"role":36,"phone":59,"phoneExt":24,"email":38},"305-243-3543",{"name":31,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":32,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Gary Farkas","Assistant Professor","100596966","gut-brain-neural-coupling-in-spinal-cord-injury-100596966",false,"NCT07052344","Gut-Brain Neural Coupling in Spinal Cord Injury","Inclusion Criteria, SCI and Controls\n\n* Adults, 18 to 70 years of age.\n* Sex, male or female.\n* Weight-stable (±3 kg) for the preceding 3 months (self-report).\n* Physically inactive adults not meeting weekly activity guidelines (\\\u003C150 min\u002Fweek) for the preceding 3 months (self-report).\n* Fluent in written and spoken English.\n\nExclusion Criteria, SCI and Controls\n\n* Do not meet the inclusion criteria.\n* Current\u002Fregular smoker (defined by Center for Disease Control (CDC)\u002F National Institute of Health (NIH) as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes either every day or every other day) (self-report).\n* Currently dieting and\u002For trying to gain or lose weight.\n* Vagus or recurrent laryngeal nerve injury (self-report).\n* Uncontrolled thyroid disease, such that they are not on thyroid medication (e.g., levothyroxine) to treat the condition (self-report)\n* Diabetes (type 1 or type 2) and\u002For currently taking anti-diabetic or glucagon-like peptide-1 (GLP-1)\u002Fdual agonist medications (self-report).\n* Gastrointestinal disease (self-report), such as inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, irritable bowel syndrome, gastroesophageal reflux disease, peptic ulcer disease, chronic pancreatitis, liver cirrhosis, and any condition requiring gastrointestinal surgery (e.g., bowel resection, colostomy, or ileostomy).\n* Swallowing disorder (self-report).\n* History of bariatric surgery\n* Food allergies\u002Fdislikes or dietary restrictions (i.e. vegan) (self-report).\n* Allergy to adhesives (self-report)\n* Open abdominal wounds or abdominal skin not intact.\n* Current use of probiotics\u002Fprebiotics (self-report).\n* Current use of medications that can impact appetite, body weight, and\u002For bowel function, such as prokinetic, antiemetic, narcotic analgesics, anticholinergic, anti-inflammatory, antipsychotic, or anti-obesity agents (self-report).\n* Pregnant (determined by urine pregnancy test) or breastfeeding women.\n* Non-adults (infants, children, teenagers).\n* Adults unable to consent\n* Prisoner.\n\nSCI-specific Eligibility Criteria\n\nInclusion Criteria, SCI Only\n\n* At least 12 months post-SCI, denoting chronic injury\n* Complete American Spinal Injury Association (ASIA) Impairment Scale (AIS A) or motor-incomplete (AIS B) tetraplegia (SCI at or above C8 lesion)\n* Able to self-feed (self-report)\n* On a bowel care program every day or every other day (self-report).\n\nExclusion Criteria, SCI Only\n\n* Under 12 months post-SCI.\n* Motor-incomplete (AIS C, D) paraplegia (SCI below C8 lesion), including thoracic, lumbar, and sacral injuries.\n* Ventilator-dependence (self-report).",true,"ALL","18 Years","70 Years",{"count":75,"type":76},28,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI).",[82],"SCI - Spinal Cord Injury","2025-11-19",{"date":85,"type":86},"2025-11-25","ACTUAL",{"date":88,"type":86},"2025-10-29",{"date":90,"type":76},"2026-12-31",{"name":5,"class":6},1]