Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 12:15 AM
Study NCT ID:
NCT04335435
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avenanthramide and Saponin Bioavailability in Oat Bran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069196', 'term': 'Gastrointestinal Microbiome'}], 'ancestors': [{'id': 'D064307', 'term': 'Microbiota'}, {'id': 'D008827', 'term': 'Microbiological Phenomena'}, {'id': 'D058448', 'term': 'Biota'}, {'id': 'D044822', 'term': 'Biodiversity'}, {'id': 'D017753', 'term': 'Ecosystem'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '0-2 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '2-4 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '4-6 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '6-9 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '9-12 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '12-24 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '24-32 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}, {'measure': 'Bioavailability of Avenanthramides and Saponins in Urine', 'timeFrame': '32-48 hours post-dose', 'description': 'Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Avenanthramides', 'Saponins', 'bioavailability', 'polyphenols', 'oat bran', 'pharmacokinetics'], 'conditions': ['Human Health', 'Polyphenols', 'Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '33694368', 'type': 'DERIVED', 'citation': 'Wang P, Zhang S, Yerke A, Ohland CL, Gharaibeh RZ, Fouladi F, Fodor AA, Jobin C, Sang S. Avenanthramide Metabotype from Whole-Grain Oat Intake is Influenced by Faecalibacterium prausnitzii in Healthy Adults. J Nutr. 2021 Jun 1;151(6):1426-1435. doi: 10.1093/jn/nxab006.'}]}, 'descriptionModule': {'briefSummary': 'Avenanthramides and saponins are types of chemical compounds found naturally in oats.\n\nAvenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and anti-proliferative effects on cancer cells in vitro. Oat saponins, or avenacosides, have the ability to bind cholesterol, and thus, the ability to lower blood cholesterol.\n\nOat bran is a known source of these dietary compounds. This study aims to determine the bioavailability of these compounds to in the urine of participants after ingesting an oat bran cereal, both before, and after for multiple time points.\n\nAnalytical chemistry will be used to determine the bioavailability of the oat compounds at each time point. This will help to establish a kinetic curve for the metabolism of these compounds.', 'detailedDescription': 'Initially, the diet of the participants will be asked to restricted to avoid eating any polyphenols that might interfere with the employed analytical chemistry techniques. This period of diet restriction is the washout period. The list of foods to avoid are: oats, whole grains, fruits, vegetables, herbal supplements, ginger, coffee, tea, and chocolate.\n\nAfter the washout period, a baseline urine and fecal sample will be collected from the participants, then a large portion of oat bran will be provided to the participants for consumption. The approximate portion size will be 100 g by dry weight. The participants will then provide urine samples during the designated time points. The time points for the urine collection are as follows:\n\n1. st sample, \\~ 30 min to 1 hour prior to oat consumption\n2. nd sample: 0-2 hours after oat consumption\n3. rd sample: 2-4 hours after oat consumption\n4. th sample: 4-6 hours after oat consumption\n5. th sample: 6-9 hours after oat consumption\n6. th sample: 9-12 hours after oat consumption\n7. th sample: 12-24 hours after oat consumption\n8. th sample: 24-32 hours after oat consumption\n9. th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC and LC/MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18.5-25\n* Have blood and urine biochemical markers in normal range\n* Have no known allergy to oat relate foods\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 waste\n\nExclusion Criteria:\n\n* Individuals with gout\n* Individuals with heart disease\n* Individuals with peripheral vascular diseases\n* Individuals with degenerative liver\n* Cancer patients\n* Patients with diabetes\n* Individuals with GI disorders\n* Individuals with endocrine disorders'}, 'identificationModule': {'nctId': 'NCT04335435', 'briefTitle': 'Avenanthramide and Saponin Bioavailability in Oat Bran', 'organization': {'class': 'OTHER', 'fullName': 'North Carolina Agriculture & Technical State University'}, 'officialTitle': 'Avenanthramide and Saponin Bioavailability in Oat Bran', 'orgStudyIdInfo': {'id': '15-0179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oat Bran Consumption', 'description': 'Each subject consumed 120 g of oat bran (by dry weight) in a single dose, and samples (urine and fecal) were collected at different time points following the administration of oat bran.', 'interventionNames': ['Dietary Supplement: Oat Bran Consumption']}], 'interventions': [{'name': 'Oat Bran Consumption', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Gut Microbiome and Oat metabolism Study'], 'description': 'Oat bran (120 g), single dose.', 'armGroupLabels': ['Oat Bran Consumption']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shengmin Sang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Carolina Agriculture and 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'}}}}