Cardiovascular Risk FactorNCT03946293
Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.
A study testing White Bread, Wholegrain bread and Wholegrain Enzyme in people with Cardiovascular Risk Factor, run by University of Reading at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- White Bread, Wholegrain bread and Wholegrain Enzyme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2015to 15 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Gluten sensitive
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP
About this study
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.
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).
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- White Bread, Wholegrain bread, Wholegrain Enzyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White BreadDietary supplement
White bread made with commercial white flour with bran/fibre removed
Wholegrain breadDietary supplement
Wholegrain bread made with commercial wholegrain flour.
Wholegrain EnzymeDietary supplement
Wholegrain bread made with enzyme-treated commercial wholegrain flour.
| Study group | Role | What they receive |
|---|---|---|
| White bread | Active comparator | White bread 3 x 30 g, single serving Receives: Dietary Supplement: White Bread |
| Wholegrain | Active comparator | Standard wholegrain, 3 x 30 g, single serving Receives: Dietary Supplement: Wholegrain bread |
| Wholegrain Enzyme | Experimental | Enzyme-treated wholegrain, 3 x 30 g, single serving Receives: Dietary Supplement: Wholegrain Enzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilatation (FMD)
FMD of the brachial artery
Measured: Change from baseline to 5 hours
Secondary outcomes (3)
Plasma phenolic acids
Presence of phenolic acid metabolites in the circulation over a 24 h period.
Measured: Change from baseline to 24 hours
Laser Doppler Imaging with iontophoresis
Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside)
Measured: Change from baseline to 5 hours
Digital Volume Pulse (DVP)
DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI)
Measured: Change from baseline to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start5 Jan 2015
- Primary completion30 Jun 2015
- Study completion15 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946293
- Sponsor's protocol ID
- Wholegrain_FMD
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33077275
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03946293
- Acronym / sponsor ID
- Wholegrain_FMD
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 15 Nov 2015 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| White bread | Active comparator | Dietary Supplement: White BreadWhite bread 3 x 30 g, single serving |
| Wholegrain | Active comparator | Dietary Supplement: Wholegrain breadStandard wholegrain, 3 x 30 g, single serving |
| Wholegrain Enzyme | Experimental | Dietary Supplement: Wholegrain EnzymeEnzyme-treated wholegrain, 3 x 30 g, single serving |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Gluten sensitive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White BreadWhite bread made with commercial white flour with bran/fibre removed | Dietary supplement | White bread |
| Wholegrain breadWholegrain bread made with commercial wholegrain flour. | Dietary supplement | Wholegrain |
| Wholegrain EnzymeWholegrain bread made with enzyme-treated commercial wholegrain flour. | Dietary supplement | Wholegrain Enzyme |
Primary outcome
Flow-mediated dilatation (FMD)
Time frame: Change from baseline to 5 hours
FMD of the brachial artery
3 secondary outcomes
Plasma phenolic acids
Time frame: Change from baseline to 24 hours
Laser Doppler Imaging with iontophoresis
Time frame: Change from baseline to 5 hours
Digital Volume Pulse (DVP)
Time frame: Change from baseline to 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 33077275Turner 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.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Risk Factor
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Targeted Health Dialogues in Primary Care
Health Behaviors, Risk Factors
Active, not recruitingObservational study
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Bread, Wholegrain bread and Wholegrain Enzyme in people with Cardiovascular Risk Factor, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilatation (FMD) (time frame: Change from baseline to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.