Cardiovascular disease Circulatory System Cardiovascular disease
Conditions
Interventions
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 rand
Sponsors
Foods Standards Agency (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed