- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02353234
Bioavailability of Phenolic Compounds in Bread
Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Parma, Italien, 43125
- University of Parma - Department of Food Science
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- BMI 18-25 kg/m2
Exclusion Criteria:
- Pregnancy and breastfeeding
- diagnosis of celiac disease
- diagnosed methabolic diseases (diabetes and disorders of glycaemic control, hypertension, dyslipidemia)
- sustained use of nutritional supplements of vitamins, in particular E and C, at the recruitment step
- chronic pharmacological therapy
- antibiotic therapy during the last 40 days
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: WHOLEGRAIN BREAD
Subjects feed with wholegrain bread, for which ferulic acid content has been quantified.
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In each arm subjects consume bread
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Aktiver Komparator: WHITE BREAD WITH ALEURONE - 4
Subjects feed with white bread with aleurone fraction in the same portion as wholegrain bread.
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In each arm subjects consume bread
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Aktiver Komparator: WHITE BREAD WITH ALEURONE - 8
Subjects feed with white bread with aleurone fraction, which contains the same quantity of ferulic acid as wholegrain bread.
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In each arm subjects consume bread
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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)
Zeitfenster: 0h; 0-3h; 3-6h; 6-10h; 10-14h; 14-24h; 24-28h; 28-34h; 34-48h.
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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. Expected Metabolites: Coumaric 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. |
0h; 0-3h; 3-6h; 6-10h; 10-14h; 14-24h; 24-28h; 28-34h; 34-48h.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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.)
Zeitfenster: 0h; 0.5h; 1h; 2h; 4h; 7h; 24h.
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Plasma samples will be collected prior (T0) and after bread consumption in each study arms. Expected Metabolites: Coumaric 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. |
0h; 0.5h; 1h; 2h; 4h; 7h; 24h.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Daniele Del Rio, Professor, University of Parma
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- Gabrielsson J, Weiner D. Non-compartmental analysis. Methods Mol Biol. 2012;929:377-89. doi: 10.1007/978-1-62703-050-2_16.
- 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.
- 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.
- 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.
- 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.
- 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.
- Truswell AS. Cereal grains and coronary heart disease. Eur J Clin Nutr. 2002 Jan;56(1):1-14. doi: 10.1038/sj.ejcn.1601283.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- DDR-001
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