Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT07121803
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007054', 'term': 'Ice Cream'}, {'id': 'C010745', 'term': 'maltitol'}, {'id': 'C120489', 'term': 'oligofructose'}, {'id': 'D007444', 'term': 'Inulin'}, {'id': 'D004896', 'term': 'Erythritol'}], 'ancestors': [{'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a double-blind cross-over study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean lower esophageal sphincter resting pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'Based on the high-resolution esophageal manometry measurement'}, {'measure': 'Distal contractile integral', 'timeFrame': 'baseline, during the intervention'}, {'measure': 'mean lower esophageal sphincter integral relaxation pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'IRP 4'}, {'measure': 'Mean contractile front velocity', 'timeFrame': 'baseline, during the intervention', 'description': 'CFV'}, {'measure': 'Distal latency', 'timeFrame': 'baseline, during the intervention', 'description': 'DL'}, {'measure': 'Mean intrabolus pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'IBP'}], 'secondaryOutcomes': [{'measure': 'mean upper esophageal sphincter resting pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'mean UES resting pressure'}, {'measure': 'Mean upper esophageal sphincter integrated relaxation pressure', 'timeFrame': 'baseline, during the intervention', 'description': 'Mean UES IRP 2 sec'}, {'measure': 'product organoleptic assessment', 'timeFrame': 'during the intervention', 'description': 'organoleptic assessment on taste, scent, colour and texture with the use of a special form based on visual-analogue scale (range: 1 - 5, where 1 is worse assessment, and 5 - favourable assessment)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal motility', 'Specialized foods', 'icecream', 'esophagus', 'motility', 'high-resolution esophageal manometry'], 'conditions': ['Ineffective Esophageal Motility', 'GERD (Gastroesophageal Reflux Disease)']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the influence of specialized products based on ice cream on esophageal motility', 'detailedDescription': 'During this study participants will be examined with the use of high-resolution esophageal motility. After standard procedure, according to Chicago IV protocol, subjects will be provided with 3 different types of food products: standard icecream (sundae), icecream with brazzein, maltitol and oligofructose; icecream with brazzein, erythritol, maltitol and inulin. Tolerability of products will be assessed based on specialized scales and formal questioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/glucose 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.'}, 'identificationModule': {'nctId': 'NCT07121803', 'acronym': 'MICE', 'briefTitle': 'The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology'}, 'officialTitle': 'Analysis of Effects of Specialized Food Products Based on Ice-Cream on Esophageal Motility', 'orgStudyIdInfo': {'id': 'OGIG-2025-MICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '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', 'interventionNames': ['Other: specialized food based on ice cream, order 1']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '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', 'interventionNames': ['Other: specialized food based on ice cream, order 2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': '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', 'interventionNames': ['Other: specialized food based on ice cream, order 3']}], 'interventions': [{'name': 'specialized food based on ice cream, order 1', 'type': 'OTHER', 'otherNames': ['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)'], 'description': '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)', 'armGroupLabels': ['Arm 1']}, {'name': 'specialized food based on ice cream, order 2', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Arm 2']}, {'name': 'specialized food based on ice cream, order 3', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115446', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey Morozov, MD, PhD', 'role': 'CONTACT', 'email': 'morosoffsv@mail.ru', 'phone': '9104681801'}, {'name': 'Armida Sasunova, MD', 'role': 'CONTACT', 'email': '84996131091@mail.ru', 'phone': '4996131091'}], 'facility': 'Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Sergey Morozov, MD, PhD', 'role': 'CONTACT', 'email': '84996131091@mail.ru', 'phone': '4996131091'}, {'name': 'Armida Sasunova, MD', 'role': 'CONTACT', 'email': 'armida.sasunova@yandex.ru', 'phone': '4996131091'}], 'overallOfficials': [{'name': 'Sergey Morozov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal Research Center of Nutrition and Biotechnology'}]}, 'ipdSharingStatementModule': {'url': 'https://ion.ru', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'within 2 years upon study completion', 'ipdSharing': 'YES', 'description': 'IPD may be shared upon reasonable request to PI', 'accessCriteria': 'Qualified persons who applied reasonable request to access the data. According to the local law, only depersonalized data may be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Russian Science Foundation', 'class': 'OTHER'}, {'name': 'Group of companies EFKO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sergey Morozov', 'investigatorAffiliation': 'Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology'}}}}