Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05517005
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2022-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine if Hype Bites increase vitamin B12 in the blood', 'timeFrame': '8 weeks', 'description': 'In order to examine the changes in B12, a blood sample will be used.'}], 'secondaryOutcomes': [{'measure': 'examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.', 'timeFrame': '8 weeks', 'description': 'Questionnaires will be given to participants throughout the trial. These questionnaires will ask about changes in their ability to focus, concentrate, their energy levels, and their mood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin Deficiency', 'Energy', 'Mood-states', 'focus'], 'conditions': ['B12 Deficiency Vitamin', 'Energy Supply; Deficiency', 'Mood']}, 'descriptionModule': {'briefSummary': "This study aims to examine the effects of Sourse's Hype Bites at being able to increase vitamin B12 levels to promote positive health outcomes. Participants will consume Hype Bites daily. Participants will also take surveys and blood samples to examine both the subjective experience of taking Hype Bites as well as changes in biomarkers across the trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 40 On a stable, consistent dietary regimen Must be on a vegan or vegetarian diet May experience the feeling of being tired often/several times a week. May experience brain fog May experience negative mood states\n\nExclusion Criteria:\n\n* Females who are pregnant or breastfeeding Currently take vitamin B12 during the past four weeks Chronic conditions such has oncological of psychiatric disorders Anyone with IBS or IBD Anyone with a previous severe allergic reaction Anyone unwilling to follow the study protocol'}, 'identificationModule': {'nctId': 'NCT05517005', 'briefTitle': 'An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sourse'}, 'officialTitle': 'An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus', 'orgStudyIdInfo': {'id': '20248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hype Bites Supplement', 'description': 'Participants will take the 2 chocolates each day, complete surveys at baseline, midpoint, and study conclusion, and take blood biomarker samples at baseline and conclusion', 'interventionNames': ['Dietary Supplement: Hype Bites Supplement']}], 'interventions': [{'name': 'Hype Bites Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The ingredients of the vitamin supplement are:\n\nChocolate liquor Sugar Cocoa butter Vanilla extract Vitamin B12 (as methylcobalamin) Tapioca Gum arabic Coloring (radish, apple, black currant) Carnauba Wax', 'armGroupLabels': ['Hype Bites Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Christopher Hill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Citruslabs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sourse', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}