Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 5:41 PM
Study NCT ID:
NCT06603194
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003483', 'term': 'Cutis Laxa'}, {'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in nail strength and growth', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Assessment of nail strength and growth will be assessed by self-perception questionnaire'}, {'measure': 'Change in skin elasticity', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Changes in skin elasticity will be measured by a cutometer'}, {'measure': 'Change in hair thickness and strength', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Strength and breakage of hair will be assessed by self perception questionnaire'}, {'measure': 'Change in skin wrinkles', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Measurement of the reduction in skin wrinkles using Profilometer'}, {'measure': 'Change in perceived skin health', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Changes in perceived skin health assessed by self perception questionnaire'}, {'measure': 'Change in skin wrinkles by visual assessment', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Change in skin wrinkles will be performed by visual assessment by a dermatologist'}, {'measure': 'Changes in skin pigmentation', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Changes in skin pigmentation will be assessed by Chromameter'}, {'measure': 'Changes in skin hydration', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Changes in skin hydration will be assessed by a Corneometer'}], 'secondaryOutcomes': [{'measure': 'Digestive Quality of Life (DQDL) Assessment', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Participants will complete a Digestive Quality of Life (DQDL) Assessment to evaluate the digestive health benefits'}, {'measure': 'Subjective Perception Questionnaire', 'timeFrame': 'Baseline, week 6 and week 12', 'description': 'Subjective Perception Questionnaire (SPQ) for Whole Body Health to capture participants\\' self-reported perceptions of their overall health and well-being'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collagen', 'Skin health', 'Skin density'], 'conditions': ['Skin Laxity', 'Hair Thinning', 'Nails']}, 'descriptionModule': {'briefSummary': 'The BECOME Study (Bovine and Marine Collagen Efficacy for Skin, Hair, Nails and Whole Body Health Markers Evaluation) is a randomized controlled trial designed to compare the effects of bovine and marine collagen supplements versus a placebo on skin, hair, nails and whole body health markers. The trial aims to determine the most efficacious collagen source for improving health outcomes and to establish if both types of collagen are equally effective. Participants will be assessed on various health parameters, including skin elasticity, joint health, digestive health, and overall well-being, over a specified period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFemales aged 35-55 years. Participants must be comfortable with bovine or marine collagen (non-vegan/vegetarian).\n\nMust provide informed consent and be willing to comply with study requirements.\n\nExclusion Criteria:\n\nPregnant or breastfeeding women. History of chronic skin conditions (e.g., eczema, psoriasis) that might interfere with study outcomes.\n\nAny active skin infections or severe acne. Currently taking collagen supplements or have taken them within the last 6 months.\n\nUse of medications or topical agents that can affect skin, hair, nails, or gastrointestinal health (e.g., corticosteroids, retinoids).\n\nExcessive alcohol consumption or current smokers. Regular use of sunbeds. Recent cosmetic procedures (e.g., Botox, fillers, chemical peels, laser treatments) on skin, hair, or nails within the last 3 months.\n\nAny condition or situation that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study requirements or give informed consent.\n\nPoor adherence to previous study protocols"}, 'identificationModule': {'nctId': 'NCT06603194', 'acronym': 'BECOME', 'briefTitle': 'Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ancient + Brave'}, 'officialTitle': 'BECOME Study: Comparative Efficacy of Bovine and Marine Collagen Versus Placebo on Skin, Hair, Nails and Whole Body Health Markers', 'orgStudyIdInfo': {'id': 'AABVIV1C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bovine Collagen', 'description': '10g powder format taken daily for duration of the study.', 'interventionNames': ['Dietary Supplement: Bovine or Marine Collagen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Marine Collagen', 'description': '10g powder format taken daily for duration of the study.', 'interventionNames': ['Dietary Supplement: Bovine or Marine Collagen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Bovine or Marine Collagen']}], 'interventions': [{'name': 'Bovine or Marine Collagen', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bovine or Marine Collagen', 'armGroupLabels': ['Bovine Collagen', 'Marine Collagen', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CM2 6UA', 'city': 'Chelmsford', 'state': 'Essex', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Becky Clarke', 'role': 'CONTACT', 'phone': '+441245934050'}], 'facility': 'Princeton Consumer Research, 8 Richmond Road, Dukes Park', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}], 'centralContacts': [{'name': 'Jenna Macciochi, PhD', 'role': 'CONTACT', 'email': 'jenna@ancientandbrave.earth', 'phone': '+447799090189'}, {'name': 'Becky Clarke', 'role': 'CONTACT', 'email': 'beckyclarke@princetonconsumer.com'}], 'overallOfficials': [{'name': 'Jenna Macciochi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'jenna@ancientandbrave.earth'}, {'name': 'Becky Clarke', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Princeton Consumer Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ancient + Brave', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Princeton Consumer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}