Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT02219295
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'C008189', 'term': 'isomaltulose'}, {'id': 'D005690', 'term': 'Galactose'}, {'id': 'D013549', 'term': 'Sweetening Agents'}, {'id': 'D012439', 'term': 'Saccharin'}, {'id': 'C010330', 'term': 'sinigrin'}, {'id': 'C001458', 'term': 'intybin'}, {'id': 'C025226', 'term': 'oxytocin, 1-alpha-mercaptoacetic acid-iso-Asn(5)-'}, {'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D051269', 'term': 'Sodium-Glucose Transporter 1'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D051247', 'term': 'Sodium-Glucose Transport Proteins'}, {'id': 'D027981', 'term': 'Symporters'}, {'id': 'D016623', 'term': 'Ion Pumps'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009004', 'term': 'Monosaccharide Transport Proteins'}, {'id': 'D000070590', 'term': 'Solute Carrier Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances', 'timeFrame': '3 years', 'description': 'oral application of sinigrin, lactucopicrin and other extracts of vegetables and umami, getting insight into the different bitter receptors'}], 'primaryOutcomes': [{'measure': 'Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists', 'timeFrame': 'three years', 'description': 'measurement of incretins (GIP, GLP-1) and peptide hormones in human plasma after consumption of different sugars , sweeteners , bitter tasting ingredients of vegetables und umami. Measurement of expression levels in human intestinal mucosa before and after receptor stimulation'}], 'secondaryOutcomes': [{'measure': 'changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression', 'timeFrame': '3 years', 'description': 'oral application of sweet tasting substances and antagonists, endoscopic collection of tissue samples, determination of molecular resonses by qRT-PCR and immunohistochemistry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SGLT1 (sodium dependent glucose transporter)', 'Glut-transporters', 'taste receptors genes', 'sweet taste receptor T1R2T1R3', 'bitter taste receptors of the hTAS2gene family'], 'conditions': ['Disorder of Glucose Regulation']}, 'referencesModule': {'references': [{'pmid': '36857956', 'type': 'DERIVED', 'citation': 'Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.'}, {'pmid': '26721819', 'type': 'DERIVED', 'citation': 'Keyhani-Nejad F, Kemper M, Schueler R, Pivovarova O, Rudovich N, Pfeiffer AF. Effects of Palatinose and Sucrose Intake on Glucose Metabolism and Incretin Secretion in Subjects With Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):e38-9. doi: 10.2337/dc15-1891. Epub 2015 Dec 30. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism. There ist growing evidence, that components of the taste signalling system, including the taste receptor proteins , have important functions in the regulation of metabolic parameters in non-gustatory tissues.', 'detailedDescription': 'We apply different sweet, bitter and umami taste compounds in a single dose in the human intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami we take glutamate.\n\nBlood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.\n\nGastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects for analysis for the presence or absence of functional taste receptors in gastrointestinal tissues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy persons\n\nExclusion Criteria:\n\n* Tumor in history\n* Pregnancy\n* Severe illness in history\n* Bodymass index below 18'}, 'identificationModule': {'nctId': 'NCT02219295', 'acronym': 'SEGATROM', 'briefTitle': 'SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'German Institute of Human Nutrition'}, 'officialTitle': 'Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition', 'orgStudyIdInfo': {'id': 'BMBF 11005D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sweet -block', 'description': 'application of different sugars, artificial sweeteners and sweet-taste antagonists in a single dose in 300 ml tap water every week up to 7 times and collection of blood samples over 3 hours', 'interventionNames': ['Dietary Supplement: sweet block', 'Dietary Supplement: bitter block', 'Dietary Supplement: umami-block']}, {'type': 'EXPERIMENTAL', 'label': 'bitter block', 'description': 'application of purified bitter tasting ingredients of vegetables and hop in 300 ml tap water , collection of blood samples for 3h (-15,0,15,30,60,120,180 min)', 'interventionNames': ['Dietary Supplement: sweet block', 'Dietary Supplement: bitter block', 'Dietary Supplement: umami-block']}, {'type': 'EXPERIMENTAL', 'label': 'umami-block', 'description': 'application of glutamate and glutamate +IMP\n\nsame procedure as above', 'interventionNames': ['Dietary Supplement: sweet block', 'Dietary Supplement: bitter block', 'Dietary Supplement: umami-block']}, {'type': 'OTHER', 'label': 'gastroscopy', 'description': 'gastroscopy with and without oral intervention with artificial sweetener saccharin to take tissue samples from the upper bowel for the investigation of taste receptor cells in the upper bowel in human beings', 'interventionNames': ['Other: gastroscopy']}], 'interventions': [{'name': 'sweet block', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sugars as sucrose, glucose, palatinose, galactose', 'artificial sweeteners as saccharin', 'sweet taste antagonist as lactisol'], 'description': 'oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin', 'armGroupLabels': ['bitter block', 'sweet -block', 'umami-block']}, {'name': 'bitter block', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['application of', 'sinigrin', 'lactucopicrin', 'iso-alpha-acid'], 'description': 'oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose', 'armGroupLabels': ['bitter block', 'sweet -block', 'umami-block']}, {'name': 'umami-block', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['application of glutamate and glutamate+IMP,'], 'description': 'oral application of umami substances as glutamate with and without IMP, collection of blood samples as above', 'armGroupLabels': ['bitter block', 'sweet -block', 'umami-block']}, {'name': 'gastroscopy', 'type': 'OTHER', 'otherNames': ['tissue samples', 'sweet taste receptor stimualtion', 'artificial sweetener saccharin', 'SGLT-1'], 'description': 'gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel', 'armGroupLabels': ['gastroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-14558', 'city': 'Bergholz-Rehbrücke', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Department of Clinical Nutrition', 'geoPoint': {'lat': 52.34719, 'lon': 13.10532}}], 'overallOfficials': [{'name': 'Andreas FH Peiffer, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Institute of Human Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Institute of Human Nutrition', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Prof. Dr. med. Andreas F. H. Pfeiffer', 'investigatorAffiliation': 'German Institute of Human Nutrition'}}}}