- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02353234
Bioavailability of Phenolic Compounds in Bread
Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Parma, Italie, 43125
- University of Parma - Department of Food Science
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Comparateur actif: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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.)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Daniele Del Rio, Professor, University of Parma
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- DDR-001
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