Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT03590756
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2018-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Mango Intake of Skin Health in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Wrinkle Depth and Redness', 'timeFrame': '0, 8, and 16 week', 'description': 'Using a skin camera from BrighTex Bio-Photonics to measure change in skin wrinkle depth and redness within a period of 16 weeks.'}, {'measure': 'Skin carotenoid', 'timeFrame': '0, 4, 8, 12, and 16 weeks', 'description': 'Using a skin photometer (Veggie Meter) to measure change in skin carotenoid within a period of 16 weeks.'}], 'secondaryOutcomes': [{'measure': 'Sebum', 'timeFrame': '0, 8, 16, weeks', 'description': 'Sebum will be collected with sebutapes from the face and stored for possible further analysis.'}, {'measure': 'Plasma carotenoid', 'timeFrame': '0, 8, 16 weeks.', 'description': 'Plasma samples will be collected and stored at -80C for possible further analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Health', 'Skin Wrinkle', 'Skin Redness', 'Carotenoid', 'Mango'], 'conditions': ['Wrinkle', 'Skin Red']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects on 16 weeks of mango intake on skin health in postmenopausal women. Half of the participants will receive 85g portions of mangoes while the other half receive 250g portions of mangos. Participants will be instructed to consume the specific portion 4 times a week, for a total duration of 16 weeks.', 'detailedDescription': 'Mangoes are rich in carotenoids, flavonoids, vitamins and other active phytochemicals such as resistant starches. Although a role of mangoes in skin health has long been advocated in traditional medicine, little scientific research has been conducted.\n\nWe hypothesize that 85g (0.5 cups) of mango intake for 16 weeks will have minimal impact on skin health, while 250g (1.5 cups) of mango intake will produce significant benefits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal\n* Fitzpatrick skin type I and II\n* BMI 18.5 - 35.0 kg/m2\n* Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician\n\nExclusion Criteria:\n\n* Allergic to mangoes\n* Fruit consumption of 2 or more cups per day\n* Vegetable consumption of 3 or more cups per day for females\n* Fruit juice consumption of more than 1 cup per day\n* Self-reported malabsorption\n* Currently taking regular prescription drugs i.e. statins, thyroid, anti-inflammatory drugs\n* Had any medical or cosmetic procedures such as laser resurfacing or plastic surgery to the face within the last 6 months, including botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure\n* Autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)\n* Smoking (current smoker, smoked within the past year, former smokers with greater than a 20 pack-year history of smoking within the past 20 years.\n* Indications of substance or alcohol abuse\n* Unwillingness to discontinue high antioxidant supplements during washout and interventions'}, 'identificationModule': {'nctId': 'NCT03590756', 'acronym': 'MSS', 'briefTitle': 'Influence of Mango Intake of Skin Health in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Influence of Mango Intake on Skin Health in Postmenopausal Women', 'orgStudyIdInfo': {'id': '1185928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High mango group', 'description': '250g (1.5 cup) of mango intake per day, 4 days a week for 16 weeks', 'interventionNames': ['Other: 16 weeks mango intake']}, {'type': 'OTHER', 'label': 'Low mango group', 'description': '85g (0.5 cup) of mango intake per day, 4 days a week for 16 weeks', 'interventionNames': ['Other: 16 weeks mango intake']}], 'interventions': [{'name': '16 weeks mango intake', 'type': 'OTHER', 'description': 'Participants will be provided fresh frozen Ataulfo mangoes.', 'armGroupLabels': ['High mango group', 'Low mango group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Ragle Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Mango Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}