[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602307":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":48,"locations":56,"responsibleParty":75,"collaborators":78,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":38,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":59,"whyStopped":38,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Federal State Budgetary Scientific Institution \"Federal Research Centre of Nutrition, Biotechnology","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Subjects of this arm will receive the following sequence of products: 1 - ice cream with brazzein, maltitol and oligofructose, 2 - ice cream with brazzein, erythritol, maltitol and inulin; 3 - standard ice cream",[13],"Other: specialized food based on ice cream, order 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Subjects of this arm will receive the following sequence of products: 1 - ice cream with brazzein, erythritol, maltitol and inulin; 2 - ice cream with brazzein, maltitol and oligofructose, 3 - standard ice cream",[18],"Other: specialized food based on ice cream, order 2",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3","Subjects of this arm will receive the following sequence of products: 1 - standard ice cream; 2 - ice cream with brazzein, maltitol and oligofructose, 3 - ice cream with brazzein, erythritol, maltitol and inulin",[23],"Other: specialized food based on ice cream, order 3",[25,34,39],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"specialized food based on ice cream, order 1","Order of intervention: 1. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose; 2: ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin; 3: standard ice cream (12% fat)",[9],[30,31,32,33],"specialized food product based on ice cream","ice cream with brazzein, maltitol and oligofructose","ice cream with brazzein, maltitol, inulin, erythritol","standard ice cream (sundae)",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"specialized food based on ice cream, order 2","1. ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin;\n2. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose;\n3. standard ice cream (12% fat)",[15],null,{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"specialized food based on ice cream, order 3","1. standard ice cream (12% fat)\n2. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose\n3. ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin",[20],[44],{"name":45,"affiliation":46,"role":47},"Sergey Morozov, MD, PhD","Federal Research Center of Nutrition and Biotechnology","PRINCIPAL_INVESTIGATOR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":38,"email":52},"CONTACT","4996131091","84996131091@mail.ru",{"name":54,"role":50,"phone":51,"phoneExt":38,"email":55},"Armida Sasunova, MD","armida.sasunova@yandex.ru",[57],{"facility":58,"status":59,"city":60,"state":38,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.","RECRUITING","Moscow","115446","Russia","RU",{"type":65,"coordinates":66},"Point",[67,68],37.61781,55.75204,{"lat":68,"lon":67},[71,74],{"name":45,"role":50,"phone":72,"phoneExt":38,"email":73},"9104681801","morosoffsv@mail.ru",{"name":54,"role":50,"phone":51,"phoneExt":38,"email":52},{"type":47,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Sergey Morozov","Principal Investigator",[79,81],{"name":80,"class":6},"Russian Science Foundation",{"name":82,"class":83},"Group of companies EFKO","UNKNOWN","100602307","the-influence-of-specialized-food-products-based-on-ice-cream-on-esophageal-motility-100602307",false,"NCT07121803","The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility","Analysis of Effects of Specialized Food Products Based on Ice-Cream on Esophageal Motility","MICE","Inclusion Criteria:\n\n* willingness to participate based on signed written informed consent;\n* controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:\n* no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);\n* doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium\u002Fglucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or insulin.\n* no new medications during participation in the study\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding;\n* Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM \\> or = 14 kPa by Fibroscan), or APRI \\> or= 1; or BARD score \\> or = 2.\n* Diarrhea of any type (watery stool more than 3 times a day).\n* Chronic heart failure (I-IV class by NYHA).\n* Past major abdominal or chest surgery, including bariatric procedures and fundoplication (except appendectomy or cholecystectomy performed more than a year before enrollment).\n* Achalasia and esophago-gastric junction outflow obstruction\n* Major esophageal motility disorders according to Chicago IV classification.\n* Clinically relevant acute cardiovascular event within 6 months prior to screening.\n* Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.\n* Diabetes mellitus type 1.\n* The level of glycated hemoglobin \\[HbA1c\\] \\>9.0%.\n* Hypersensitivity to the studied product or any of its components, including lactose intolerance.\n* The intake of any pharmaceutical agents with known influence on esophageal motility (including, but not limited to: beta-blockers, calcium channel blockers, m-cholinoblockers, myorelaxants, antidepressants, tranquilizers, prokinetic agents)\n* Any medical conditions that may significantly affect life expectancy, including known cancers;\n* Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases;\n* Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol;\n* Inability to tolerate high-resolution esophageal manometry without sedation, at least in part.",true,"ALL","18 Years","80 Years",{"count":97,"type":98},30,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study aims to assess the influence of specialized products based on ice cream on esophageal motility",[104,105],"Ineffective Esophageal Motility","GERD (Gastroesophageal Reflux Disease)",[107,108,109,110,111,112],"Esophageal motility","Specialized foods","icecream","esophagus","motility","high-resolution esophageal manometry","2025-08-07",{"date":115,"type":116},"2025-08-14","ACTUAL",{"date":118,"type":116},"2025-07-01",{"date":120,"type":98},"2025-12-31",{"name":5,"class":6},1]