ISRCTN ISRCTN47748735
DOI https://doi.org/10.1186/ISRCTN47748735
Secondary identifying numbers 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

Study designA single-blind, single-centre, randomised, controlled dietary intervention study with three parallel treatment arms (one control and two intervention groups)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleImpact of increasing doses of flavonoid-rich and flavonoid-poor fruit and vegetables on cardiovascular risk factors in an ‘at risk’ group
Study acronymFLAVURS
Study objectivesTo 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) studiedCardiovascular disease
InterventionAfter 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 typeOther
Primary outcome measureEach 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 measures1. 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 study start date19/11/2007
Completion date30/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants180
Key inclusion criteria1. 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 criteriaPeople:
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 enrolment19/11/2007
Date of final enrolment30/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hugh Sinclair Human Nutrition Unit
Reading
RG6 6AP
United Kingdom

Sponsor information

Foods Standards Agency (UK)
Government

Aviation House
125 Kingsway
London
WC2 6NH
United Kingdom

Website http://www.foodstandards.gov.uk/
ROR logo "ROR" https://ror.org/05p20a626

Funders

Funder type

Government

Foods Standards Agency (UK) (ref: N02R0001)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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