Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-31 @ 7:02 PM
Study NCT ID:
NCT05668156
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2022-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding Consensus in Fasting Terminology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Definitions of fasting regimens', 'timeFrame': 'repetition of the survey until consensus is reached, max. 12 months', 'description': 'Definitions of fasting regimen (qualitative research) with max. five survey rounds and potentially one online discussion panel'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['consensus', 'fasting', 'fasting terminology', 'therapeutic fasting', 'Delphi', 'Delphi method', 'decision-making', 'intermittent fasting', 'periodic fasting', 'prolonged fasting', 'religious fasting', 'intermittent dry fasting', 'caloric restriction', 'diet', 'nutrition'], 'conditions': ['Consensus Development']}, 'descriptionModule': {'briefSummary': 'A consensus-based decision making process on fasting terminology will be conducted using the Delphi technique. To this aim, experts around the world are invited.', 'detailedDescription': "The consensus-based decision making process on fasting terminology will include a maximum of five rounds of questionnaires that experts are invited to complete online using a pseudonym. Prof. Dr. med. Michalsen's department has prepared rough definitions of key terms for the questionnaire to be evaluated by the experts. These terms should serve as a starting point for the discussion. After each questionnaire round the experts' comments are reviewed by the project team and a new questionnaire with the suggested modifications from the previous round will be sent to the experts.\n\nIf consensus can't be reached by round three, a live-online-discussion will be held to facilitate the further proceedings.\n\nThe results are to be published in a peer-reviewed journal; individual statements will not be shared in the publication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'clinicians or scientists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinicians or scientists with at least 5 peer-reviewed publications on fasting or\n* at least one peer-reviewed publication and 5 years of clinical experience with fasting\n\nExclusion Criteria:\n\n\\- not more than 2 experts from one institution are allowed to participate'}, 'identificationModule': {'nctId': 'NCT05668156', 'acronym': 'FT', 'briefTitle': 'Finding Consensus in Fasting Terminology', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Defining Fasting: Finding Common Ground Using the Delphi Method', 'orgStudyIdInfo': {'id': 'Delphi'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Consensus Decision Making', 'type': 'OTHER', 'description': 'Consensus-based decision-making process, where experts are asked to comment definitions of terms used for fasting interventions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}