FLAVonoids: University of Reading Study

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN47748735
• Lead Sponsor: Foods Standards Agency (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified