Contact information
Type
Scientific
Primary contact
Dr Julie Lovegrove
ORCID ID
Contact details
Hugh Sinclair Human Nutrition Unit
School of Chemistry
Food Biosciences and Pharmacy
University of Reading
Whiteknights
Reading
RG6 6AP
United Kingdom
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j.a.lovegrove@reading.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N02R0001
Study information
Scientific title
Impact of increasing doses of flavonoid-rich and flavonoid-poor fruit and vegetables on cardiovascular risk factors in an at risk group
Acronym
FLAVURS
Study hypothesis
To determine the impact of different amounts and types (flavonoid-rich versus flavonoid-poor) of fruit and vegetables on heart disease risk factors in an 'at risk' group.
Ethics approval
Ethics approval received from the Isle of Wight, Portsmouth and South East Hampshire Research Ethics Committee on 6th November 2007 (REC no.: 07/H0501/81).
Study design
A single-blind, single-centre, randomised, controlled dietary intervention study with three parallel treatment arms (one control and two intervention groups)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Cardiovascular disease
Intervention
After a three week run-in period following a habitual (low fruit and vegetable) diet, 180 participants, selected on the basis of their increased risk of developing cardiovascular disease, will be randomly assigned to either the habitual diet (control) or one of two intervention groups, which involves the increased intake of flavonoid-rich or flavonoid-poor fruits and vegetables. In both intervention groups, participants will be asked to sequentially increase their fruit and vegetable intake by 2, 4 and 6 portions, with a 6-week duration for each dose increase. The intervention phase will last for 18-weeks. Due to the duration of the study, a parallel design is adopted to minimise burden on the participants. The control group is necessary to control for the impact of study participation and seasonal effects on the outcomes of the study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Each subject has to attend four intervention visits in total for the study. The following primary outcome measures will be taken at each visit:
1. Changes in endothelial function measured by vascular reactivity and arterial stiffness using Laser Doppler Imaging with iontophoresis and Pulse Wave Analysis measurement respectively
2. Plasma biomarkers of endothelial function (e.g. nitric oxide, Vascular Cell Adhesion Molecule [VCAM], Intercellular Adhesion Molecule [ICAM], E-selectin, von Willebrand factor, microalbumin) - fasting bloods will be taken at each visit to measure these outcomes
Secondary outcome measures
1. Fasting bloods will be taken during each intervention visit to measure the following outcomes:
1.1. Fasting lipids (total, Low Density Lipoprotein [LDL] cholesterol, HDL cholesterol, triglycerides and non-esterified fatty acids)
1.2. Indices of insulin resistance
1.3. Haemostatic factors (Plasminogen Activator Inhibitor 1 [PAI-1], fibrinogen)
1.4. Inflammatory biomarkers (C-Reactive Protein [CRP], Tumour Necrotising Factor [TNF]-alpha and Interleukin-6 [IL6])
2. The following will be measured during the 6-week intervention periods between visits:
2.1. 24-hour ambulatory blood pressure
2.2. Dietary intake assessed by 24 hour dietary recalls and biomarkers of fruit and vegetable intake (24 hour urinary flavonoid metabolites, urinary potassium, plasma ascorbic acid)
3. Faecal samples will be collected at each intervention visit to perform quantitative and qualitative analysis of faecal microflora and estimation of faecal water genotoxicity and mucosal integrity
4. Changes in cognitive performance will be measured during each intervention visits using computer tests
Overall trial start date
19/11/2007
Overall trial end date
30/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women between the ages of 30 - 70 years
2. At above average risk of developing heart disease
3. Meet one or more of the following criteria:
3.1. Overweight
3.2. High total cholesterol (but not on medication)
3.3. Low High Density Lipoprotein (HDL) cholesterol
3.4. High blood pressure (but not on medication)
3.5. Cigarette smoker
For the specific range of inclusion for each risk factor, we have come up with a scoring system, adapted mainly from the Framingham study. Volunteers who have an above average risk of developing heart disease (RR 1.5) would be included in the study. Volunteers who have risk factor/s at a very high risk level would be excluded. Participants should also have a low intake of fruit and vegetable (i.e. less than or equal to 3 portions per day).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
People:
1. Who have diabetes, heart disease (previous stroke/myocardial infarction), renal or bowel or liver diseases and hormone abnormalities
2. On drug treatment for hyperlipidemia, hypertension, inflammation or hypercoagulation
3. Taking dietary supplements (e.g. vitamins and minerals, fish oils)
4. Who drink more than 15 units of alcohol per week
5. Who are pregnant, lactating or if of reproductive age and not using a reliable form of contraception (including abstinence)
6. Who are regularly undertaking vigorous exercise or fitness training
7. Who are on a weight-reducing regime
8. Who consume over 3 portions of fruit and vegetables per day
Recruitment start date
19/11/2007
Recruitment end date
30/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hugh Sinclair Human Nutrition Unit
Reading
RG6 6AP
United Kingdom
Sponsor information
Organisation
Foods Standards Agency (UK)
Sponsor details
Aviation House
125 Kingsway
London
WC2 6NH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Foods Standards Agency (UK) (ref: N02R0001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results published as a poster at ICPH 2009: Yorkshire 7th December-11th December
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22476876
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24452238
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25332486
Publication citations
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Results
Chong MF, George TW, Alimbetov D, Jin Y, Weech M, Macready AL, Spencer JP, Kennedy OB, Minihane AM, Gordon MH, Lovegrove JA, Impact of the quantity and flavonoid content of fruits and vegetables on markers of intake in adults with an increased risk of cardiovascular disease: the FLAVURS trial., Eur J Nutr, 2013, 52, 1, 361-378, doi: 10.1007/s00394-012-0343-3.
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Results
Macready AL, George TW, Chong MF, Alimbetov DS, Jin Y, Vidal A, Spencer JP, Kennedy OB, Tuohy KM, Minihane AM, Gordon MH, Lovegrove JA, , Flavonoid-rich fruit and vegetables improve microvascular reactivity and inflammatory status in men at risk of cardiovascular disease--FLAVURS: a randomized controlled trial., Am. J. Clin. Nutr., 2014, 99, 3, 479-489, doi: 10.3945/ajcn.113.074237.
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Results
Jin Y, Gordon MH, Alimbetov D, Chong MF, George TW, Spencer JP, Kennedy OB, Tuohy K, Minihane AM, Lovegrove JA; FLAVURS Study Group, A novel combined biomarker including plasma carotenoids, vitamin C, and ferric reducing antioxidant power is more strongly associated with fruit and vegetable intake than the individual components, J Nutr, 2014, 144, 11, 1866-1872, doi: 10.3945/jn.114.192856.