Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT03911050
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2019-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-01', 'releaseDate': '2025-03-13'}], 'estimatedResultsFirstSubmitDate': '2025-03-13'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption', 'timeFrame': '0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in urine'}, {'measure': 'Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption', 'timeFrame': '0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be used to assess RCS adducts of apple polyphenols in plasma'}, {'measure': 'Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption', 'timeFrame': '0, 24, 48 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples'}], 'secondaryOutcomes': [{'measure': 'Change in urinary levels of RCS over 24 hours after one single dose of apple consumption', 'timeFrame': '0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in urine'}, {'measure': 'Change in plasma levels of RCS over 24 hours after one single dose of apple consumption', 'timeFrame': '0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endogenous reactive carbonyl species', 'apple consumption', 'formation of carbonyl species adducts of apple polyphenols', 'pharmacokinetics of adducts in human', 'intervention'], 'conditions': ['Human Health', 'Polyphenols', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.', 'detailedDescription': 'A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.\n\nOn week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.\n\nOn the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.\n\nSamples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 17 and 30\n* Have blood and urine biochemical markers in normal range\n* Have no known allergy to apples\n* Be not taking antibiotics for six months\n* Be not currently taking medication\n* Be nonsmoking\n* Have no alcoholic intoxication\n* Have no extensive exposure to industrial wastes\n* Be not frequent charred meat consumption\n\nExclusion Criteria:\n\n* Individuals with gout\n* Individuals with heart diseases\n* Individuals with peripheral vascular diseases\n* Individuals with degenerative kidney\n* Individuals with degenerative liver\n* Cancer patients\n* Patients with diabetes\n* Individuals with GI disorders\n* Individuals with endocrine disorders'}, 'identificationModule': {'nctId': 'NCT03911050', 'briefTitle': 'Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human', 'organization': {'class': 'OTHER', 'fullName': 'North Carolina Agriculture & Technical State University'}, 'officialTitle': 'Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects', 'orgStudyIdInfo': {'id': '18-0089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apple consumption', 'description': 'Each subject took apple blends 600 g (made from two apples with seed removal) in a single dose, and samples (urine and blood and feces) at different timepoints were collected following administration of apple blends.', 'interventionNames': ['Dietary Supplement: Apple consumption']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Each subject took breakfast without any apple-related products in a single dose, and samples (urine and blood and feces) at different timepoints were collected following breakfast.', 'interventionNames': ['Dietary Supplement: Control group']}], 'interventions': [{'name': 'Apple consumption', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Apple blends (600 g) One single dose', 'armGroupLabels': ['Apple consumption']}, {'name': 'Control group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast without any apple-related products', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Agriculture and Technical State University', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}], 'overallOfficials': [{'name': 'Shengmin Sang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Carolina Agriculture & Technical State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Carolina Agriculture & Technical State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shengmin Sang', 'investigatorAffiliation': 'North Carolina Agriculture & Technical State University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-13', 'type': 'RELEASE'}, {'date': '2025-04-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shengmin Sang, Principal Investigator, North Carolina Agriculture & Technical State University'}}}}