Clinical trial NCT02353234: Bioavailability of Phenolic Compounds in Bread
Official title: Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: Phenolics
Aleurone
Bioavailability
Pharmacokinetics
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma - Department of Food Science
Study officials:
affiliation: University of Parma
name: Daniele Del Rio, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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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.
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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.