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

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.

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: White Bread; Dietary supplement: Wholegrain bread; Dietary supplement: Wholegrain Enzyme

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Biotechnology and Biological Sciences Research Council

Publications and helpful links

General Publications

• Turner AL, Michaelson LV, Shewry PR, Lovegrove A, Spencer JPE. 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. Clin Nutr. 2021 Mar;40(3):788-795. doi: 10.1016/j.clnu.2020.07.026. Epub 2020 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2015
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): November 15, 2015

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Wholegrain_FMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No