Flavonoids, Blood Pressure and Blood Vessel Function
FASTCHECK
Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
1 other identifier
interventional
64
1 country
1
Brief Summary
The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk. The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 28, 2014
February 1, 2014
1.8 years
February 1, 2012
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration.
Assessment of vascular function
acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied
Secondary Outcomes (1)
Differences in effects of flavonoids introduced by food matrix
acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied
Study Arms (4)
Intervention group A: flavanones
EXPERIMENTALAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest.
Intervention group B: isoflavones
EXPERIMENTALAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest.
Intervention group C: Flavan-3-ols
EXPERIMENTALAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest.
Intervention group D: Anthocyanins
EXPERIMENTALAll experimental days will be exactly the same. All volunteers will attend the clinical research and trial unit in a fasted state. Prior to test administration, baseline vascular function will be assessed and biological samples taken by a trained and qualified research nurse. Subsequently, assessments will be repeated at times corresponding to anticipated peak plasma concentration of the flavonoid of interest.
Interventions
acute single optimal dose of commercial product
acute single optimal dose
acute single optimal dose
Eligibility Criteria
You may qualify if:
- Males
- to 75 years old
- At elevated risk of CV disease
- Screening blood pressure of \< 160/90mmHg (at rest)
- Successful biochemical, haematological and urinalysis assessment at screening (as judged by clinical advisor)
You may not qualify if:
- Current smokers, or ex-smokers ceasing \< 3 months ago
- Subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures (as judged by clinical advisor)
- Those with known allergies to the intervention treatments
- Those unprepared to adhere to dietary restrictions during the trial
- Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material
- Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
- Taking flavonoid containing food / dietary supplements likely to affect the study results
- Prescribed lipid lowering, hypertension, vasodilators (e.g. Viagra) or antibiotic medication
- Unsatisfactory biochemical, haematological or urinary assessment at screening, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition, Norwich Medical School
Norwich, Norfolk, NR4 7TJ, United Kingdom
Related Publications (2)
Hazim S, Curtis PJ, Schar MY, Ostertag LM, Kay CD, Minihane AM, Cassidy A. Acute benefits of the microbial-derived isoflavone metabolite equol on arterial stiffness in men prospectively recruited according to equol producer phenotype: a double-blind randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):694-702. doi: 10.3945/ajcn.115.125690. Epub 2016 Feb 3.
PMID: 26843154DERIVEDSchar MY, Curtis PJ, Hazim S, Ostertag LM, Kay CD, Potter JF, Cassidy A. Orange juice-derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease. Am J Clin Nutr. 2015 May;101(5):931-8. doi: 10.3945/ajcn.114.104364. Epub 2015 Mar 18.
PMID: 25788001DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Aedin Cassidy, PhD
University of East Anglia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 10, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 28, 2014
Record last verified: 2014-02