Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 3:21 AM
Study NCT ID:
NCT06800833
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C501277', 'term': 'Mangifera indica extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of sexual health questionnaire scores', 'timeFrame': 'Baseline and week 4', 'description': 'Change of sexual health questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.'}, {'measure': 'Change of depression questionnaire scores', 'timeFrame': 'Baseline and week 4', 'description': 'Change of depression questionnaire scores will be determined to examine effects of mango consumption vs low-fat cookies.'}, {'measure': 'Change of skin hydration scores', 'timeFrame': 'Baseline, 1 min post application and week 4consumption', 'description': 'Change of skin hydration scores will be determined to examine effects of mango consumption vs low-fat cookies'}, {'measure': 'Change of microbiome diversity', 'timeFrame': 'Baseline and week 4', 'description': 'Change of microbiome diversity will be determined to examine effects of mango consumption vs low-fat cookies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gut Microbiome']}, 'descriptionModule': {'briefSummary': 'The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy subjects\n* BMI 20-40 kg/m2\n\nExclusion Criteria:\n\n* Smoker\n* Pregnant woman\n* Required antibiotics use\n* Required dietary supplement use\n* Required medication of metabolic disorders, mental health and sexual health\n* Allergy to mango or wheat'}, 'identificationModule': {'nctId': 'NCT06800833', 'briefTitle': 'Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health', 'orgStudyIdInfo': {'id': 'IRB-25-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low fat cookies', 'description': 'Subjects consume 100 kcal of low-fat cookies daily for 4 weeks.', 'interventionNames': ['Other: Low fat cookies']}, {'type': 'EXPERIMENTAL', 'label': 'Mango', 'description': 'Subjects consume 100 kcal of mango daily for 4 weeks.', 'interventionNames': ['Other: Mango']}], 'interventions': [{'name': 'Low fat cookies', 'type': 'OTHER', 'description': 'To determine the effects of low fat cookie consumption on physiological indicators of sexual, mental, skin, and gut health', 'armGroupLabels': ['Low fat cookies']}, {'name': 'Mango', 'type': 'OTHER', 'description': 'To determine the effects of mango consumption on physiological indicators of sexual, mental, skin, and gut health', 'armGroupLabels': ['Mango']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mee Young Hong', 'role': 'CONTACT', 'email': 'mhong2@sdsu.edu', 'phone': '619-594-6825'}], 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}