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Completed

NCT Number: NCT03946293

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

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).

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Key information

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

White Bread

Dietary Supplement

White bread made with commercial white flour with bran/fibre removed

Wholegrain bread

Dietary Supplement

Wholegrain bread made with commercial wholegrain flour.

Wholegrain Enzyme

Dietary Supplement

Wholegrain bread made with enzyme-treated commercial wholegrain flour.

Primary outcomes

  1. Flow-mediated dilatation (FMD)

    Time frame: Change from baseline to 5 hours

    FMD of the brachial artery

Secondary outcomes

  1. Plasma phenolic acids

    Time frame: Change from baseline to 24 hours

    Presence of phenolic acid metabolites in the circulation over a 24 h period.

  2. Laser Doppler Imaging with iontophoresis

    Time frame: Change from baseline to 5 hours

    Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside)

  3. Digital Volume Pulse (DVP)

    Time frame: Change from baseline to 5 hours

    DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI)

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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