Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03946293 |
|
Recruitment Status :
Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Risk Factor | Dietary Supplement: White Bread Dietary Supplement: Wholegrain bread Dietary Supplement: Wholegrain Enzyme | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 5, 2015 |
| Actual Primary Completion Date : | June 30, 2015 |
| Actual Study Completion Date : | November 15, 2015 |
| 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. |
- Flow-mediated dilatation (FMD) [ Time Frame: Change from baseline to 5 hours ]FMD of the brachial artery
- Plasma phenolic acids [ Time Frame: Change from baseline to 24 hours ]Presence of phenolic acid metabolites in the circulation over a 24 h period.
- Laser Doppler Imaging with iontophoresis [ Time Frame: Change from baseline to 5 hours ]Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside)
- Digital Volume Pulse (DVP) [ Time Frame: Change from baseline to 5 hours ]DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946293
| United Kingdom | |
| Department of Food and Nutritional Sciences | |
| Reading, Berkshire, United Kingdom, RG6 6AP | |
| Responsible Party: | Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading |
| ClinicalTrials.gov Identifier: | NCT03946293 |
| 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 |