Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
Study NCT ID:
NCT06808061
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Microbiome Balance', 'timeFrame': '12 weeks'}, {'measure': 'Mood State', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'probiotic', 'psychobiotic', 'weight loss', 'body composition', 'obesity', 'depression', 'dysbiosis'], 'conditions': ['Weight Loss', 'Mood']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (Lactobacillus plantarum KABP-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass).\n\nOur subjects will be measured 4 times over the course of a 12-week supplementation period - at Baseline, Week 4, Week 8, and Week 12.\n\nWe will have 2 groups (N=30 per group):\n\n* Probiotic Lactobacillus plantarum KABP-51\n* Placebo (maltodextrin/corn starch) Subjects will be recruited from local fitness/wellness centers and businesses (e.g. Plymouth Fitness; Planet Fitness; Marathon Sports, etc) using a simple flyer.\n\nIf volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF) before any Baseline measurements are collected.\n\nParticipants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. This periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts.\n\nOur expectation is that this fairly simple 12-week design will show that the KABP-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy moderately overweight\n\nExclusion Criteria:\n\n* Pregnant women\n* Inability to complete prescribed supplement regimen\n* Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)'}, 'identificationModule': {'nctId': 'NCT06808061', 'briefTitle': 'Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults', 'organization': {'class': 'INDUSTRY', 'fullName': '3 Waves Wellness'}, 'officialTitle': 'Effects of Kaneka KABP-51 Probiotic on Mood, Metabolism, Microbiome, and Body Composition in Healthy Adults', 'orgStudyIdInfo': {'id': 'KABPWeightMood2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Lactobacillus plantarum KABP-51; 1-billion CFU', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus plantarum KABP-51', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': '3Waves Wellness', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3 Waves Wellness', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaneka Americas Holding Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientist', 'investigatorFullName': 'Shawn Talbott', 'investigatorAffiliation': '3 Waves Wellness'}}}}