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

NCT ID: NCT03946293

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-05

Study Completion Date

2015-11-15

Brief Summary

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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

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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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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White bread

White bread 3 x 30 g, single serving

Group Type ACTIVE_COMPARATOR

White Bread

Intervention Type DIETARY_SUPPLEMENT

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

Wholegrain

Standard wholegrain, 3 x 30 g, single serving

Group Type ACTIVE_COMPARATOR

Wholegrain bread

Intervention Type DIETARY_SUPPLEMENT

Wholegrain bread made with commercial wholegrain flour.

Wholegrain Enzyme

Enzyme-treated wholegrain, 3 x 30 g, single serving

Group Type EXPERIMENTAL

Wholegrain Enzyme

Intervention Type DIETARY_SUPPLEMENT

Wholegrain bread made with enzyme-treated commercial wholegrain flour.

Interventions

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White Bread

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

Intervention Type DIETARY_SUPPLEMENT

Wholegrain bread

Wholegrain bread made with commercial wholegrain flour.

Intervention Type DIETARY_SUPPLEMENT

Wholegrain Enzyme

Wholegrain bread made with enzyme-treated commercial wholegrain flour.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotechnology and Biological Sciences Research Council

OTHER

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor of Nutritional Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Food and Nutritional Sciences

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33077275 (View on PubMed)

Other Identifiers

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Wholegrain_FMD

Identifier Type: -

Identifier Source: org_study_id

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