Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 8:01 AM
Study NCT ID:
NCT03946293
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2015-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated dilatation (FMD)', 'timeFrame': 'Change from baseline to 5 hours', 'description': 'FMD of the brachial artery'}], 'secondaryOutcomes': [{'measure': 'Plasma phenolic acids', 'timeFrame': 'Change from baseline to 24 hours', 'description': 'Presence of phenolic acid metabolites in the circulation over a 24 h period.'}, {'measure': 'Laser Doppler Imaging with iontophoresis', 'timeFrame': 'Change from baseline to 5 hours', 'description': 'Laser Doppler Imaging with iontophoresis (acetyl choline and sodium nitroprusside)'}, {'measure': 'Digital Volume Pulse (DVP)', 'timeFrame': 'Change from baseline to 5 hours', 'description': 'DVP stiffness index (DVP-SI) and DVP reflexion index (DVP-RI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk Factor']}, 'referencesModule': {'references': [{'pmid': '33077275', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) 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.\n\nExclusion Criteria:\n\n* Gluten sensitive'}, 'identificationModule': {'nctId': 'NCT03946293', 'briefTitle': 'Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'Wholegrain_FMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'White bread', 'description': 'White bread 3 x 30 g, single serving', 'interventionNames': ['Dietary Supplement: White Bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wholegrain', 'description': 'Standard wholegrain, 3 x 30 g, single serving', 'interventionNames': ['Dietary Supplement: Wholegrain bread']}, {'type': 'EXPERIMENTAL', 'label': 'Wholegrain Enzyme', 'description': 'Enzyme-treated wholegrain, 3 x 30 g, single serving', 'interventionNames': ['Dietary Supplement: Wholegrain Enzyme']}], 'interventions': [{'name': 'White Bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'White bread made with commercial white flour with bran/fibre removed', 'armGroupLabels': ['White bread']}, {'name': 'Wholegrain bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Wholegrain bread made with commercial wholegrain flour.', 'armGroupLabels': ['Wholegrain']}, {'name': 'Wholegrain Enzyme', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Wholegrain bread made with enzyme-treated commercial wholegrain flour.', 'armGroupLabels': ['Wholegrain Enzyme']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AP', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Department of Food and Nutritional Sciences', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotechnology and Biological Sciences Research Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutritional Medicine', 'investigatorFullName': 'Jeremy Paul Edward Spencer', 'investigatorAffiliation': 'University of Reading'}}}}