Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT07045766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FaibaLite - Reduce Weight, One Bite at a Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Mono-centre, single-arm, open-label feasibility study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate', 'timeFrame': 'Up to 3 months (end of chewing phase)', 'description': 'Feasibility will be assessed as a composite endpoint including the following parameters among healthy adults:\n\n* Participant adherence rate (percentage of recommended chewing performed)\n* User acceptance score (based on questionnaire)\n* Dropout rate (percentage of participants who discontinue the study prematurely)'}], 'secondaryOutcomes': [{'measure': 'Duration of intervention', 'timeFrame': 'Up to 3 months after study start', 'description': 'Duration of the study intervention, e.g. the willingness to continue FibreGum consumption for an additional month after 2 months of intervention'}, {'measure': 'Reduction in body weight (%)', 'timeFrame': '2 or 3 months', 'description': 'Reduction in percent of body weight between baseline and end of intervention'}, {'measure': 'Change in body composition (body fat)', 'timeFrame': '2 or 3 months', 'description': 'Difference in body fat\\* (if available) between baseline and end of intervention\n\n\\*This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment'}, {'measure': 'Change in body composition (lean mass)', 'timeFrame': '2 or 3 months', 'description': 'Difference in lean mass\\* (if available) between baseline and end of intervention\n\n\\*This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment'}, {'measure': 'Change in body composition (muscle mass)', 'timeFrame': '2 or 3 months', 'description': 'Difference in muscle mass\\* (if available) between baseline and end of intervention\n\n\\*This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment'}, {'measure': 'Change in gut microbiota alpha-diversity', 'timeFrame': '2 months', 'description': 'Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics'}, {'measure': 'Change in gut microbiota beta-diversity', 'timeFrame': '2 months', 'description': 'Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics'}, {'measure': 'Change in differential abundance of gut microbiota', 'timeFrame': '2 months', 'description': 'Change in the relative abundance of specific bacterial taxa between baseline and timepoint 2, assessed by metagenomic sequencing'}, {'measure': 'Changes in body weight during follow-up', 'timeFrame': '1 or 2 months', 'description': 'Changes in body weight from completion of intervention to end of study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chewing gum', 'Galactooligosaccharides', 'GOS (Galactooligosaccharides)', 'Intestinal microbiome', 'Gut microbiota'], 'conditions': ['Nutritional and Metabolic Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the suitability of a fiber-enriched chewing gum as a practical and accessible approach to support healthy body weight management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written Informed Consent\n* Healthy adults aged 18 to 65 years (inclusive), as determined by the investigator\n* BMI of 23 to 40 kg/m2 (inclusive)\n* Living in Switzerland\n* Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing)\n* Access and willingness to use an electronic device (e.g., mobile phone, computer or tablet)\n* Access to a scale to self-report weight\n\nExclusion Criteria:\n\n* Current weight loss therapy with Glucagon-like Peptide 1 (GLP-1) agonists or other non-prescription products (at investigator's discretion)\n* Treatment with a GLP-1 agonist within the past 2 months\n* Initiation/Discontinuation of nicotine product use (\\>1 nicotine product per day, e.g., (e-)cigarette, gum) within the last 2 months (at investigator's discretion)\n* Significant change in medication within the last 2 months (at investigator's discretion)\n* Unable to chew gum 3 times daily (e.g. due to dental issues, at investigator's discretion)"}, 'identificationModule': {'nctId': 'NCT07045766', 'briefTitle': 'FaibaLite - Reduce Weight, One Bite at a Time', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'FaibaLite - Reduce Weight, One Bite at a Time', 'orgStudyIdInfo': {'id': 'FaibaLite'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FibreGum Intervention Group', 'description': 'Participants chew one fiber-containing gum (FibreGum) three times daily (morning, noon, and evening) for at least 20 minutes each, over two months, with the option to extend the intervention to three months.', 'interventionNames': ['Dietary Supplement: FibreGum chewing gum']}], 'interventions': [{'name': 'FibreGum chewing gum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Chewing gum containing galactooligosaccharides (GOS), delivering a total daily dose of 3 g of dietary fiber.', 'armGroupLabels': ['FibreGum Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'CONTACT', 'email': 'maria.balmer@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}], 'facility': 'Department of Biomedical Research, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'CONTACT', 'email': 'maria.balmer@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}, {'name': 'Janina N Zünd, PhD', 'role': 'CONTACT', 'email': 'janina.zuend@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}], 'overallOfficials': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Research, University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'DCB Research AG', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}