Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 10:00 PM
Study NCT ID:
NCT02353234
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Phenolic Compounds in Bread
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001939', 'term': 'Bread'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenolic compound bioavailability in wholegrain bread compared with bread enriched with aleurone fraction (urine samples will be filtered and diluted and phenolic compound metabolites will be identified)', 'timeFrame': '0h; 0-3h; 3-6h; 6-10h; 10-14h; 14-24h; 24-28h; 28-34h; 34-48h.', 'description': 'Volunteers will collect urine before consuming bread (T0) and for 48 hours after the consumption of the meal test, in each study arms. Urine samples will be collected and stored at -80°C until uHPLC/MS analysis. Prior analysis, urine samples will be filtered and diluted and phenolic compound metabolites will be identified.\n\nExpected Metabolites:\n\nCoumaric acid, Hydroxyphenylpropionic acid, Dihydroxyphenylacetic acid, Hippuric acid, Enterolactone, Enterodiol, Coumaric acid sulphate, Phenylpropionic acid sulphate, Vanillic acid sulphate, Hydroxyphenylpropionic acid sulphate, Ferulic acid sulphate, Dihydroferulic acid sulphate, Hydroxyphenylpropionic acid glucuronide, Ferulic acid glucuronide, Enterolactone sulphate, Enterodiol sulphate, Enterolactone glucuronide, Enterodiol glucuronide.'}], 'secondaryOutcomes': [{'measure': 'Phenolic compound pharmacokinetics in wholegrain bread compared with bread enriched with aleurone fraction (metabolites identified in Plasma samples that will be collected prior (T0) and after bread consumption in each study arms.)', 'timeFrame': '0h; 0.5h; 1h; 2h; 4h; 7h; 24h.', 'description': 'Plasma samples will be collected prior (T0) and after bread consumption in each study arms.\n\nExpected Metabolites:\n\nCoumaric acid, Hydroxyphenylpropionic acid, Dihydroxyphenylacetic acid, Hippuric acid, Enterolactone, Enterodiol, Coumaric acid sulphate, Phenylpropionic acid sulphate, Vanillic acid sulphate, Hydroxyphenylpropionic acid sulphate, Ferulic acid sulphate, Dihydroferulic acid sulphate, Hydroxyphenylpropionic acid glucuronide, Ferulic acid glucuronide, Enterolactone sulphate, Enterodiol sulphate, Enterolactone glucuronide, Enterodiol glucuronide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phenolics', 'Aleurone', 'Bioavailability', 'Pharmacokinetics'], 'conditions': ['Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '19537710', 'type': 'BACKGROUND', 'citation': 'Anson NM, Selinheimo E, Havenaar R, Aura AM, Mattila I, Lehtinen P, Bast A, Poutanen K, Haenen GR. Bioprocessing of wheat bran improves in vitro bioaccessibility and colonic metabolism of phenolic compounds. J Agric Food Chem. 2009 Jul 22;57(14):6148-55. doi: 10.1021/jf900492h.'}, {'pmid': '22794138', 'type': 'BACKGROUND', 'citation': 'Del Rio D, Rodriguez-Mateos A, Spencer JP, Tognolini M, Borges G, Crozier A. Dietary (poly)phenolics in human health: structures, bioavailability, and evidence of protective effects against chronic diseases. Antioxid Redox Signal. 2013 May 10;18(14):1818-92. doi: 10.1089/ars.2012.4581. Epub 2012 Aug 27.'}, {'pmid': '23007438', 'type': 'BACKGROUND', 'citation': 'Gabrielsson J, Weiner D. Non-compartmental analysis. Methods Mol Biol. 2012;929:377-89. doi: 10.1007/978-1-62703-050-2_16.'}, {'pmid': '11902973', 'type': 'BACKGROUND', 'citation': 'Kikuzaki H, Hisamoto M, Hirose K, Akiyama K, Taniguchi H. Antioxidant properties of ferulic acid and its related compounds. J Agric Food Chem. 2002 Mar 27;50(7):2161-8. doi: 10.1021/jf011348w.'}, {'pmid': '24977665', 'type': 'BACKGROUND', 'citation': 'Calani L, Ounnas F, Salen P, Demeilliers C, Bresciani L, Scazzina F, Brighenti F, Melegari C, Crozier A, de Lorgeril M, Del Rio D. Bioavailability and metabolism of hydroxycinnamates in rats fed with durum wheat aleurone fractions. Food Funct. 2014 Aug;5(8):1738-46. doi: 10.1039/c4fo00328d.'}, {'pmid': '17313706', 'type': 'BACKGROUND', 'citation': 'Luceri C, Giannini L, Lodovici M, Antonucci E, Abbate R, Masini E, Dolara P. p-Coumaric acid, a common dietary phenol, inhibits platelet activity in vitro and in vivo. Br J Nutr. 2007 Mar;97(3):458-63. doi: 10.1017/S0007114507657882.'}, {'pmid': '22336890', 'type': 'BACKGROUND', 'citation': 'Mateo Anson N, Hemery YM, Bast A, Haenen GR. Optimizing the bioactive potential of wheat bran by processing. Food Funct. 2012 Apr;3(4):362-75. doi: 10.1039/c2fo10241b. Epub 2012 Feb 15. No abstract available.'}, {'pmid': '19460943', 'type': 'BACKGROUND', 'citation': 'Stalmach A, Mullen W, Barron D, Uchida K, Yokota T, Cavin C, Steiling H, Williamson G, Crozier A. Metabolite profiling of hydroxycinnamate derivatives in plasma and urine after the ingestion of coffee by humans: identification of biomarkers of coffee consumption. Drug Metab Dispos. 2009 Aug;37(8):1749-58. doi: 10.1124/dmd.109.028019. Epub 2009 May 21.'}, {'pmid': '20226754', 'type': 'BACKGROUND', 'citation': 'Stalmach A, Steiling H, Williamson G, Crozier A. Bioavailability of chlorogenic acids following acute ingestion of coffee by humans with an ileostomy. Arch Biochem Biophys. 2010 Sep 1;501(1):98-105. doi: 10.1016/j.abb.2010.03.005. Epub 2010 Mar 11.'}, {'pmid': '11840174', 'type': 'BACKGROUND', 'citation': 'Truswell AS. Cereal grains and coronary heart disease. Eur J Clin Nutr. 2002 Jan;56(1):1-14. doi: 10.1038/sj.ejcn.1601283.'}, {'pmid': '24450764', 'type': 'BACKGROUND', 'citation': "Zaupa M, Scazzina F, Dall'Asta M, Calani L, Del Rio D, Bianchi MA, Melegari C, De Albertis P, Tribuzio G, Pellegrini N, Brighenti F. In vitro bioaccessibility of phenolics and vitamins from durum wheat aleurone fractions. J Agric Food Chem. 2014 Feb 19;62(7):1543-9. doi: 10.1021/jf404522a. Epub 2014 Feb 6."}]}, 'descriptionModule': {'briefSummary': 'The consumption of wholemeal cereals has been associated with the reduction of several chronic diseases. The mechanisms behind these protective effects may be linked, besides dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly, hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the highest concentration of ferulic acid, principally contained as monomeric form and diferulic acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary excretion of phenolic metabolites in humans fed with two different kind of a commercial bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the pharmacokinetics of the main phenolic compounds was also evaluated by measuring the circulating metabolites in plasma samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-25 kg/m2\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding\n* diagnosis of celiac disease\n* diagnosed methabolic diseases (diabetes and disorders of glycaemic control, hypertension, dyslipidemia)\n* sustained use of nutritional supplements of vitamins, in particular E and C, at the recruitment step\n* chronic pharmacological therapy\n* antibiotic therapy during the last 40 days'}, 'identificationModule': {'nctId': 'NCT02353234', 'briefTitle': 'Bioavailability of Phenolic Compounds in Bread', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction', 'orgStudyIdInfo': {'id': 'DDR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WHOLEGRAIN BREAD', 'description': 'Subjects feed with wholegrain bread, for which ferulic acid content has been quantified.', 'interventionNames': ['Other: Bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WHITE BREAD WITH ALEURONE - 4', 'description': 'Subjects feed with white bread with aleurone fraction in the same portion as wholegrain bread.', 'interventionNames': ['Other: Bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WHITE BREAD WITH ALEURONE - 8', 'description': 'Subjects feed with white bread with aleurone fraction, which contains the same quantity of ferulic acid as wholegrain bread.', 'interventionNames': ['Other: Bread']}], 'interventions': [{'name': 'Bread', 'type': 'OTHER', 'description': 'In each arm subjects consume bread', 'armGroupLabels': ['WHITE BREAD WITH ALEURONE - 4', 'WHITE BREAD WITH ALEURONE - 8', 'WHOLEGRAIN BREAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43125', 'city': 'Parma', 'country': 'Italy', 'facility': 'University of Parma - Department of Food Science', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Daniele Del Rio, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniele Del Rio', 'investigatorAffiliation': 'University of Parma'}}}}