FLAVonoids: University of Reading Study

ISRCTN	ISRCTN47748735
DOI	https://doi.org/10.1186/ISRCTN47748735
Protocol serial number	N02R0001
Sponsor	Foods Standards Agency (UK)
Funder	Foods Standards Agency (UK) (ref: N02R0001)

Submission date: 12/11/2007
Registration date: 11/12/2007
Last edited: 13/01/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Julie Lovegrove
Scientific

Hugh Sinclair Human Nutrition Unit
School of Chemistry, Food Biosciences and Pharmacy
University of Reading
Whiteknights
Reading
RG6 6AP
United Kingdom

Email	j.a.lovegrove@reading.ac.uk

Study information

Primary study design	Interventional
Study design	A single-blind, single-centre, randomised, controlled dietary intervention study with three parallel treatment arms (one control and two intervention groups)
Secondary study design	Randomised controlled trial
Scientific title	Impact of increasing doses of flavonoid-rich and flavonoid-poor fruit and vegetables on cardiovascular risk factors in an at risk group
Study acronym	FLAVURS
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	180
Key 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).
Key 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
Date of first enrolment	19/11/2007
Date of final enrolment	30/10/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hugh Sinclair Human Nutrition Unit

Reading
RG6 6AP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013	Yes	No
Results article	results	01/03/2014	Yes	No
Results article	results	01/11/2014	Yes	No