Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of a high phenolic acid intake from wholegrain wheat bread on human vascular function and plasma phenolic acid concentrations in healthy adults. All participants received a high fibre flatbread with enzymatically released free FA (14.22 mg), an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg).

Detailed Description
-----------------
Clinical trial data have indicated an association between wholegrain consumption and a reduction in surrogate markers of cardiovascular disease. A number of components of wheat have been suggested to contribute to the cardiovascular health benefits associated with wholegrain consumption, most notably the fiber component. However, phenolic compounds that are bound to arabinoxylan fibre, particularly the hydroxycinnamate ferulic acid, may also contribute, in part, to vascular health effects. These phenolics may be more active when released enzymatically from the fiber prior to ingestion. The aim of the present study was therefore to determine whether the intake of high fibre bread containing higher free ferulic acid levels (enzymatically released during processing) enhances human endothelium-dependent vascular function to a greater extent than that of traditional wholegrain bread and/or a white bread control.

Official Title
-----------------
Increased Bioavailability of Phenolic Acids and Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread: a Randomized, Controlled, Single Blind, Crossover Human Intervention Trial.

Conditions
-----------------
Cardiovascular Risk Factor

Intervention / Treatment
-----------------
* Dietary Supplement: White Bread
* Dietary Supplement: Wholegrain bread
* Dietary Supplement: Wholegrain Enzyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) fasting lipids in the upper half of the normal range (triacylglycerol 0.8-3.2 mmol/l and total cholesterol 6.0-8.0 mmol/l); 2) BMI 25-32 kg/m2; 3) non-smoker; 4) not diabetic (diagnosed or fasting glucose < 7 mmol/l) or suffer from endocrine disorders; 5) hemoglobin and liver enzymes levels within the normal range [Alanine Transaminase (ALT): 0-55 IU/L; Alkaline Phosphatase (ALP): 38-126 U/L; Aspartate Transaminase (AST): 0-45 IU/L; Gamma Glutamyl Transferase (GGT): 12-58 IU/L]); 6) not having suffered a myocardial infarction/stroke in the past 12 months; 7) not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis; 8) not on drug treatment for hyperlipidemia, hypertension, inflammation or hyper-coagulation; 9) not taking any fish oil, fatty acid or vitamin and mineral supplements; 10) no history of alcohol misuse; 11) not planning, or on a weight reduction regime; 12) not having taken antibiotics in the 6 months prior to the study; and 13) being able to consume the study interventions. Exclusion Criteria: Gluten sensitive

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: White bread<br>White bread 3 x 30 g, single serving | Dietary Supplement: White Bread<br>* White bread made with commercial white flour with bran/fibre removed<br>|
| Active Comparator: Wholegrain<br>Standard wholegrain, 3 x 30 g, single serving | Dietary Supplement: Wholegrain bread<br>* Wholegrain bread made with commercial wholegrain flour.<br>|
| Experimental: Wholegrain Enzyme<br>Enzyme-treated wholegrain, 3 x 30 g, single serving | Dietary Supplement: Wholegrain Enzyme<br>* Wholegrain bread made with enzyme-treated commercial wholegrain flour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilatation (FMD) | FMD of the brachial artery | Change from baseline to 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma phenolic acids | Presence of phenolic acid metabolites in the circulation over a 24 h period. | Change from baseline to 24 hours | 
| Laser Doppler Imaging with iontophoresis | Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside) | Change from baseline to 5 hours | 
| Digital Volume Pulse (DVP) | DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI) | Change from baseline to 5 hours |