Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05274334
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One arm, Proof of Concept Study assessing metabolites in exhaled breath of healthy adults.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial', 'timeFrame': 'approximately 4.5 hours', 'description': 'Variation of signal intensity of deuterated exhaled metabolites across the approximately lasting 4.5 hours trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deuterium resolved mass spectrometry', 'exhaled breath', 'deuterium enrichment', 'metabolome of exhaled breath', 'deuterated exhaled metabolites'], 'conditions': ['De Novo Lipogenesis (DNL)']}, 'descriptionModule': {'briefSummary': 'This proof of concept- study is to measure de novo lipogenesis (DNL) non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.', 'detailedDescription': "The study objective is to measure the DNL by ingestion of a single oral dose of 70% 2H2O at 2 g/kg body-water. The subjects will consume a Yoghurt consisting of 300g of 'Excellence Joghurt Nature gezuckert' which contains 410 Kcal, 28g fat, 34g carbohydrates and 9g protein. The exhaled air of the subjects will be measured several times per hour to analyse de novo lipogenesis (DNL) non-invasive by deuterium resolved mass spectrometry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteers\n* English speaking, or good knowledge of the English language\n* Able to understand the study\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT05274334', 'acronym': 'D2OBREATH', 'briefTitle': 'Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Basel"}, 'officialTitle': 'Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis', 'orgStudyIdInfo': {'id': '2022-00099; ks22Sinues'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Assessment of de novo lipogenesis non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.', 'interventionNames': ['Other: Assessment of de novo lipogenesis non-invasively in exhaled breath']}], 'interventions': [{'name': 'Assessment of de novo lipogenesis non-invasively in exhaled breath', 'type': 'OTHER', 'description': "1. Healthy participants have a good nights sleep whereas they don't eat during the night and until measurements.\n2. They come to the lab and make first baseline exhalation sets. An exhalation set consists of 6 exhalations in Mass Spectrometer positive mode and the same in negative mode. One exhalation set takes around 7minutes from start to finish.\n3. Participants consume a single oral dose of dose of 70% 2H2O at 2 g/kg body-water.\n4. Participants execute several exhalation sets over time.\n5. Participants consume 300g of 'Excellence Joghurt Nature gezuckert.\n6. Participants execute several exhalation sets over time.\n7. After around 4.5hours with regular exhalation sets taking place, the trial is concluded.", 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'country': 'Switzerland', 'facility': "University Children's Hospital Basel (UKBB)", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Pablo Sinues, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäts-Kinderspital beider Basel (UKBB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital Basel", 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}, {'name': 'Fondation Botnar', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}