Flavonoids, Blood Pressure and Blood Vessel Function (FASTCHECK)
This study is not yet open for participant recruitment.
Verified February 2012 by University of East Anglia
Sponsor:
University of East Anglia
Information provided by (Responsible Party):
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01530893
First received: February 1, 2012
Last updated: February 7, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease Risk Reduction |
Dietary Supplement: Flavanone - supplement Other: Flavanone - food Other: Flavanone - placebo Dietary Supplement: Isoflavone - supplement Other: Isoflavone - food Other: Isoflavone - placebo Dietary Supplement: Isoflavone - metabolite supplement Dietary Supplement: Flavan-3-ol - supplement Other: Flavan-3-ol - food Other: Flavan-3-ol - placebo Dietary Supplement: Anthocyanin - supplement Other: Anthocyanin - food Other: Anthocyanin - placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Are the Cardiovascular Responses of Individuals at Mild to Moderate Cardiovascular Risk Influenced by Dietary Flavonoid Sub-class and Dietary Form? |
Resource links provided by NLM:
Further study details as provided by University of East Anglia:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Assessment of vascular function
Secondary Outcome Measures:
- Differences in effects of flavonoids introduced by food matrix [ Time Frame: acute postprandial; up to 24 hours dependent on flavonoid sub-classification studied ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Dietary Supplement: Flavanone - supplement
acute single optimal dose
Other: Flavanone - food
acute single dose
Other: Flavanone - placebo
acute single dose (flavanone free)
|
|
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.
|
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
|
|
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.
|
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)
|
|
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.
|
Dietary Supplement: Anthocyanin - supplement
acute single optimal dose
Other: Anthocyanin - food
acute single optimal dose
Other: Anthocyanin - placebo
acute single dose (anthocyanin free)
|
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:
- dietary flavonoid + placebo supplement
- placebo food + commercially available/produced flavonoid supplement
- 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.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530893
Contacts
| Contact: Peter J Curtis, PhD | (+44) 1603 591873 | P.Curtis@uea.ac.uk |
| Contact: Aedìn Cassidy, PhD | (+44) 1603 591539 | A.Cassidy@uea.ac.uk |
Locations
| United Kingdom | |
| Department of Nutrition, Norwich Medical School | Not yet recruiting |
| Norwich, Norfolk, United Kingdom, NR4 7TJ | |
| Contact: Michael Turco (+44) 1603 593746 M.Turco@uea.ac.uk | |
| Contact: Sara Hazim S.Hazim@uea.ac.uk | |
| Principal Investigator: Aedin Cassidy, PhD | |
| Sub-Investigator: John F Potter, MD | |
| Sub-Investigator: Anne-Marie Minihane, PhD | |
| Sub-Investigator: Peter J Curtis, PhD | |
| Sub-Investigator: Sara Hazim | |
| Sub-Investigator: Manuel Y Schaer | |
Sponsors and Collaborators
University of East Anglia
Investigators
| Principal Investigator: | Aedin Cassidy, PhD | University of East Anglia |
More Information
No publications provided
| Responsible Party: | University of East Anglia |
| ClinicalTrials.gov Identifier: | NCT01530893 History of Changes |
| Other Study ID Numbers: | FASTCHECK |
| Study First Received: | February 1, 2012 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of East Anglia:
|
flavonoids vascular function randomised controlled trial placebo controlled |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013