Study Results
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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COMPLETED
NA
64 participants
INTERVENTIONAL
2012-02-29
2013-12-31
Brief Summary
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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.
Detailed Description
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A target of 60 participants will be required to complete the study and a total of 70 subjects will be targeted (n=70 subjects \* \~85% anticipated completion rate = 60 subjects to complete the study).
This placebo-controlled study will test the relative efficacy of 4 different flavonoid sub-classes ((i) flavan-3-ol, (ii) anthocyanin, (iii) flavanone and (iv) isoflavone).
Accordingly, subjects will be randomised to one of the four flavonoid study groups ((i) to (iv) outlined above), and then will consume each of the following treatments in random order:
1. dietary flavonoid + placebo supplement
2. placebo food + commercially available/produced flavonoid supplement
3. placebo food + placebo supplement
Additionally, an isoflavone metabolite will be fed to establish potential vascular effects.
Each sub-class will be assessed separately and a 1 week wash-out period between treatments will be observed.
At each assessment visit, vascular function will be assessed pre- and post-intervention, with subsequent assessments made to coincide with anticipated peak plasma concentrations.
Dietary intake will be monitored during the study and participants will be required to adhere to a range of dietary and lifestyle restrictions within 3 days of each assessment to reduce potential confounding of the data assessment of interest.
A standard battery of vascular function tests will be performed on all intervention groups, with each assessment visit performed in an identical manner.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Intervention group A: flavanones
All 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.
Flavanone - supplement
acute single optimal dose
Flavanone - food
acute single dose
Flavanone - placebo
acute single dose (flavanone free)
Intervention group B: isoflavones
All 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.
Isoflavone - supplement
acute single optimal dose
Isoflavone - food
acute single optimal dose
Isoflavone - placebo
acute single dose (isoflavone free)
Isoflavone - metabolite supplement
acute single optimal dose of commercial product
Intervention group C: Flavan-3-ols
All 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.
Flavan-3-ol - supplement
acute single optimal dose
Flavan-3-ol - food
acute single optimal dose
Flavan-3-ol - placebo
acute single dose (flavan-3-ol free)
Intervention group D: Anthocyanins
All 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.
Anthocyanin - supplement
acute single optimal dose
Anthocyanin - food
acute single optimal dose
Anthocyanin - placebo
acute single dose (anthocyanin free)
Interventions
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Flavanone - supplement
acute single optimal dose
Flavanone - food
acute single dose
Flavanone - placebo
acute single dose (flavanone free)
Isoflavone - supplement
acute single optimal dose
Isoflavone - food
acute single optimal dose
Isoflavone - placebo
acute single dose (isoflavone free)
Isoflavone - metabolite supplement
acute single optimal dose of commercial product
Flavan-3-ol - supplement
acute single optimal dose
Flavan-3-ol - food
acute single optimal dose
Flavan-3-ol - placebo
acute single dose (flavan-3-ol free)
Anthocyanin - supplement
acute single optimal dose
Anthocyanin - food
acute single optimal dose
Anthocyanin - placebo
acute single dose (anthocyanin free)
Eligibility Criteria
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Inclusion Criteria
* 50 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)
Exclusion Criteria
* 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
50 Years
75 Years
MALE
Yes
Sponsors
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University of East Anglia
OTHER
Responsible Party
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Principal Investigators
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Aedin Cassidy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Department of Nutrition, Norwich Medical School
Norwich, Norfolk, United Kingdom
Countries
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References
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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.
Schar 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.
Other Identifiers
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FASTCHECK
Identifier Type: -
Identifier Source: org_study_id