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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03946293

Recruitment Status Completed

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

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).

  • Condition or Disease:Cardiovascular Risk Factor
  • Intervention/Treatment: Dietary Supplement: White Bread
    Dietary Supplement: Wholegrain bread
    Dietary Supplement: Wholegrain Enzyme
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 19 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention
  • 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.
  • Actual Study Start Date: January 2015
  • Actual Primary Completion Date: June 2015
  • Actual Study Completion Date: November 2015
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Flow-mediated dilatation (FMD) [ Time Frame: Change from baseline to 5 hours ]
    FMD of the brachial artery
  • Secondary Outcome Measures: 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)
Eligibility Criteria
  • Ages Eligible for Study: 20 to 55 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

United Kingdom, Berkshire
Department of Food and Nutritional Sciences
Reading

Sponsors and Collaborators

University of Reading

Biotechnology and Biological Sciences Research Council

More Information
  • Responsible Party: University of Reading
  • ClinicalTrials.gov Identifier: NCT03946293 History of Changes
  • Other Study ID Numbers: Wholegrain_FMD
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No