Cardiovascular Disease Risk Reduction
Conditions
Keywords
flavonoids, vascular function, randomised controlled trial, placebo controlled
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.
Detailed description
The study population will be healthy males (aged 50-75 years) at elevated risk of cardiovascular (CV) disease. 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.
Interventions
DIETARY_SUPPLEMENTFlavanone - supplement
acute single optimal dose
OTHERFlavanone - food
acute single dose
OTHERFlavanone - placebo
acute single dose (flavanone free)
DIETARY_SUPPLEMENTIsoflavone - supplement
acute single optimal dose
OTHERIsoflavone - food
acute single optimal dose
OTHERIsoflavone - placebo
acute single dose (isoflavone free)
DIETARY_SUPPLEMENTIsoflavone - metabolite supplement
acute single optimal dose of commercial product
DIETARY_SUPPLEMENTFlavan-3-ol - supplement
acute single optimal dose
OTHERFlavan-3-ol - food
acute single optimal dose
OTHERFlavan-3-ol - placebo
acute single dose (flavan-3-ol free)
DIETARY_SUPPLEMENTAnthocyanin - supplement
acute single optimal dose
OTHERAnthocyanin - food
acute single optimal dose
OTHERAnthocyanin - placebo
acute single dose (anthocyanin free)
Sponsors
University of East Anglia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Males * 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration. | acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied | Assessment of vascular function |
Secondary
| Measure | Time frame |
|---|---|
| Differences in effects of flavonoids introduced by food matrix | acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied |
Countries
United Kingdom
Outcome results
None listed