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Clinical Trials/ISRCTN47748735
ISRCTN47748735
Completed
Not Applicable

Impact of increasing doses of flavonoid-rich and flavonoid-poor fruit and vegetables on cardiovascular risk factors in an ?at risk? group

Foods Standards Agency (UK)0 sites180 target enrollmentDecember 11, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Foods Standards Agency (UK)
Enrollment
180
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 11, 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Foods Standards Agency (UK)

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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