Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02253056
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}, {'id': 'D000072001', 'term': 'Diet, Healthy'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin-like growth factor 1 and brain-derived neurotrophic factor', 'timeFrame': 'Baseline and after 8 weeks', 'description': 'Measurement of changes after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaire: WHO-5', 'timeFrame': 'Baseline, 8 weeks, 6 month', 'description': 'Questionnaire'}, {'measure': 'Profile of mood states questionnaire: POMS', 'timeFrame': 'Baseline, 8 weeks, 6 month', 'description': 'Questionnaire'}, {'measure': 'Anxiety and depression questionnaire: HADS', 'timeFrame': 'Baseline, 8 weeks, 6 month', 'description': 'Questionnaire'}, {'measure': 'Flourishing questionnaire', 'timeFrame': 'Baseline, 8 weeks, 6 month', 'description': 'Questionnaire'}, {'measure': 'Visual analogue scales and Likert-scales', 'timeFrame': 'Baseline, 8 weeks, 6 month', 'description': 'Questionnaire'}, {'measure': 'Body Impedance Analysis (BIA)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement of changes after 8 weeks'}, {'measure': 'Body weight and abdominal circumference', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement of changes after 8 weeks'}, {'measure': 'Systolic and diastolic bloodpressure', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement of changes after 8 weeks'}, {'measure': 'Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Changes after 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fasting', 'Caloric Restriction', 'Focus is to observe effects of fasting in healthy volunteers.'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.naturheilkunde.immanuel.de', 'label': 'Research Institute´s Homepage'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to evaluate the effects of one regular fasting day per week over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.', 'detailedDescription': 'Participants in the intervention group receive an initial group training for fasting. Then all participants will observe one fixed fasting day per week (monday) over a total period of eight weeks.\n\nParticipants in the control group receive an initial group training for healthy diet according to current German guidelines (DGE). Moreover, they will receive the same offer as in the intervention group at the end of the 8-week study period. Until then the control group participants follow a regular healthy diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 -65 yrs\n* written informed consent\n\nExclusion Criteria:\n\n* severe chronic comorbidity\n* eating disorders\n* pregnancy\n* planed pregnancy\n* simultaneous participation in other trials'}, 'identificationModule': {'nctId': 'NCT02253056', 'acronym': 'MIFT', 'briefTitle': 'Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]', 'orgStudyIdInfo': {'id': 'MIFT-Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting', 'description': 'Intermittent fasting over 8 weeks (one day per week)', 'interventionNames': ['Other: Fasting / Caloric Restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy diet', 'description': 'Regular healthy diet according to current German (DGE) guidelines for healthy nutrition.', 'interventionNames': ['Other: Healthy Diet']}], 'interventions': [{'name': 'Fasting / Caloric Restriction', 'type': 'OTHER', 'armGroupLabels': ['Fasting']}, {'name': 'Healthy Diet', 'type': 'OTHER', 'armGroupLabels': ['Healthy diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14109', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Immanuel Hospital Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Immanuel Hospital, Berlin, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Andreas Michalsen', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}