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

Cardiovascular Risk Factor Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946293
• Other study ID #: Wholegrain_FMD
• Status: Completed
• Phase: N/A
• Start date: January 5, 2015
• Est. completion date: November 15, 2015

Study information

• Verified date: May 2019
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 15, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• White Bread
White bread made with commercial white flour with bran/fibre removed
• Wholegrain bread
Wholegrain bread made with commercial wholegrain flour.
• Wholegrain Enzyme
Wholegrain bread made with enzyme-treated commercial wholegrain flour.

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Biotechnology and Biological Sciences Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilatation (FMD)	FMD of the brachial artery	Change from baseline to 5 hours
Secondary	Plasma phenolic acids	Presence of phenolic acid metabolites in the circulation over a 24 h period.	Change from baseline to 24 hours
Secondary	Laser Doppler Imaging with iontophoresis	Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside)	Change from baseline to 5 hours
Secondary	Digital Volume Pulse (DVP)	DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI)	Change from baseline to 5 hours