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Flavonoids, Blood Pressure and Blood Vessel Function (FASTCHECK)

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ClinicalTrials.gov Identifier: NCT01530893
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
University of East Anglia

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration. [ Time Frame: acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied ]
Assessment of vascular function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Differences in effects of flavonoids introduced by food matrix [ Time Frame: acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flavonoids, Blood Pressure and Blood Vessel Function
Official Title  ICMJE Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cardiovascular Disease Risk Reduction
Intervention  ICMJE
  • Dietary Supplement: Flavanone - supplement
    acute single optimal dose
  • Other: Flavanone - food
    acute single dose
  • Other: Flavanone - placebo
    acute single dose (flavanone free)
  • Dietary Supplement: Isoflavone - supplement
    acute single optimal dose
  • Other: Isoflavone - food
    acute single optimal dose
  • Other: Isoflavone - placebo
    acute single dose (isoflavone free)
  • Dietary Supplement: Isoflavone - metabolite supplement
    acute single optimal dose of commercial product
  • Dietary Supplement: Flavan-3-ol - supplement
    acute single optimal dose
  • Other: Flavan-3-ol - food
    acute single optimal dose
  • Other: 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
  • Other: Anthocyanin - placebo
    acute single dose (anthocyanin free)
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Flavanone - supplement
    • Other: Flavanone - food
    • Other: Flavanone - placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Isoflavone - supplement
    • Other: Isoflavone - food
    • Other: Isoflavone - placebo
    • Dietary Supplement: Isoflavone - metabolite supplement
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Flavan-3-ol - supplement
    • Other: Flavan-3-ol - food
    • Other: Flavan-3-ol - placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: Anthocyanin - supplement
    • Other: Anthocyanin - food
    • Other: Anthocyanin - placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2014)
64
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
70
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530893
Other Study ID Numbers  ICMJE FASTCHECK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of East Anglia
Study Sponsor  ICMJE University of East Anglia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aedin Cassidy, PhD University of East Anglia
PRS Account University of East Anglia
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP