Cardiovascular Disease Risk Reduction Clinical Trial
Official title:
Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01935362 -
Impact of Oranges on Cardiovascular Health
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05259150 -
The Health for Hearts United Collaborative
|
N/A |