Bioavailability of Phenolic Compounds in Bread

Study Overview
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Brief Summary
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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.

Official Title
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Bioavailability of Phenolic Compounds in Wholegrain Bread Compared With White Bread Enriched With Aleurone Fraction

Conditions
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Dietary Modification

Intervention / Treatment
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* Other: Bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WHOLEGRAIN BREAD<br>Subjects feed with wholegrain bread, for which ferulic acid content has been quantified. | Other: Bread<br>* In each arm subjects consume bread<br>|
| Active Comparator: WHITE BREAD WITH ALEURONE - 4<br>Subjects feed with white bread with aleurone fraction in the same portion as wholegrain bread. | Other: Bread<br>* In each arm subjects consume bread<br>|
| Active Comparator: WHITE BREAD WITH ALEURONE - 8<br>Subjects feed with white bread with aleurone fraction, which contains the same quantity of ferulic acid as wholegrain bread. | Other: Bread<br>* In each arm subjects consume bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenolics, Aleurone, Bioavailability, Pharmacokinetics