Flavonoids, Blood Pressure and Blood Vessel Function

Cardiovascular Disease Risk Reduction Clinical Trial

— FASTCHECK  

Official title:

Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530893
• Other study ID #: FASTCHECK
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: February 27, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Reduction
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Flavanone - supplement
acute single optimal dose

Other:
• Flavanone - food
acute single dose
• Flavanone - placebo
acute single dose (flavanone free)

Dietary Supplement:
• Isoflavone - supplement
acute single optimal dose

Other:
• Isoflavone - food
acute single optimal dose
• Isoflavone - placebo
acute single dose (isoflavone free)

Dietary Supplement:
• Isoflavone - metabolite supplement
acute single optimal dose of commercial product
• Flavan-3-ol - supplement
acute single optimal dose

Other:
• Flavan-3-ol - food
acute single optimal dose
• Flavan-3-ol - placebo
acute single dose (flavan-3-ol free)

Dietary Supplement:
• Anthocyanin - supplement
acute single optimal dose

Other:
• Anthocyanin - food
acute single optimal dose
• Anthocyanin - placebo
acute single dose (anthocyanin free)

Locations

Country	Name	City	State
United Kingdom	Department of Nutrition, Norwich Medical School	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Differences in effects of flavonoids introduced by food matrix		acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied	No