Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 9:28 PM
Study NCT ID:
NCT04706806
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019342', 'term': 'Acetic Acid'}], 'ancestors': [{'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Both groups received vinegar, either liquid form (active) or pill form (placebo)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mood state', 'timeFrame': 'change from baseline at day 28', 'description': 'Profile of Mood States (POMS) questionnaire score'}, {'measure': 'depression', 'timeFrame': 'change from baseline at day 28', 'description': 'Center for Epidemiologic Studies Depression Scale (CES-D)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acetic acid'], 'conditions': ['Mood', 'Depression']}, 'descriptionModule': {'briefSummary': 'The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion.', 'detailedDescription': 'Recent research suggests that fruit and vegetable intake is inversely associated with mood states and depression. Although the mechanism is not known, increased gut fermentation is suspected as changes in gut tryptophan metabolism was noted in these trials. Tryptophan is the precursor to serotonin, the neurotransmitter associated with improved mood state, but other metabolites of tryptophan have been associated with mental wellbeing as well. The main ingredient of vinegar, acetic acid, is the most common metabolite produced during gut fermentation of dietary fiber (mainly from fruits and vegetables) and can also be expected to influence the gut microbiome. It has been reported that vinegar ingestion is linked to a change in tryptophan metabolism in healthy adults consuming vinegar daily for 8 weeks. This study will explore the impact of vinegar ingestion on mood states.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* college student, non-athlete, no chronic health condition\n\nExclusion Criteria:\n\n* vegetarians or others adhering to special diet, body mass index \\>30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar'}, 'identificationModule': {'nctId': 'NCT04706806', 'acronym': 'VIN2020', 'briefTitle': 'Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students', 'orgStudyIdInfo': {'id': 'STUDY00012406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'liquid vinegar', 'description': '2 tablespoons (diluted in water) taken twice daily with meals', 'interventionNames': ['Dietary Supplement: apple cider vinegar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vinegar pill', 'description': '1 vinegar pill taken daily', 'interventionNames': ['Dietary Supplement: vinegar pill']}], 'interventions': [{'name': 'apple cider vinegar', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['apple cider vinegar (Bragg Live Food Products, LLC)'], 'description': '2 tablespoons diluted in water taken twice daily with meals', 'armGroupLabels': ['liquid vinegar']}, {'name': 'vinegar pill', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ["Nature's Bounty Apple Cider Vinegar pills"], 'description': 'one pill taken daily', 'armGroupLabels': ['vinegar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Associate Dean', 'investigatorFullName': 'Carol Johnston', 'investigatorAffiliation': 'Arizona State University'}}}}