Diet and Vascular Health Study

NCT01114399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-07-29

No results posted yet for this study

Summary

The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular disease risk using biochemical indicators such as blood lipid profiles, most notably cholesterol; markers of inflammation as well as established physiological measurements such as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure Measurements (ABPM). Broccoli contains compounds known as glucosinolates which are metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought to be the principal component in broccoli that may reduce CVD risk. The investigators will use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates ('HG broccoli'). This broccoli has been used in previous intervention studies (e.g. ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the broccoli) parallel study. The volunteers recruited will, according to the Joint British Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or having a cardiovascular (CV) event in the next 10 years.

Conditions

Interventions

DIETARY_SUPPLEMENT

Diet and Vascular Health

One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.

DIETARY_SUPPLEMENT

Diet and Vascular Health

One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.

DIETARY_SUPPLEMENT

Diet and Vascular Health Study

One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.

Sponsors & Collaborators

  • Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

    collaborator OTHER
  • University of East Anglia

    collaborator OTHER
  • Quadram Institute Bioscience

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114399 on ClinicalTrials.gov