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Diet and Vascular Health Study (BROCCOLI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114399
First Posted: May 3, 2010
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
University of East Anglia
Information provided by (Responsible Party):
Quadram Institute
  Purpose
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.

Condition Intervention
Cardiovascular Disease Dietary Supplement: Diet and Vascular Health Dietary Supplement: Diet and Vascular Health Study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Diet and Vascular Health Study

Further study details as provided by Quadram Institute:

Primary Outcome Measures:
  • Examination of the indicators of CVD after the consumption of broccoli, high glucosinolate broccoli and peas. [ Time Frame: Week 12 ]
    To examine the effects of a diet rich in broccoli on the systemic indicators of CVD including total cholesterol as well as established physiological measurements such as ambulatory blood pressure (BP), Augmentation Index (AIx) and Pulse Wave velocity (PWV) in subjects with a mild to moderate (10-20%) risk of developing CVD within the next 10 years


Secondary Outcome Measures:
  • The determination of key polymorphic genes of the trial subjects [ Time Frame: Baseline ]
    To determine the genotype of individuals for key polymorphic genes (GSTM1, GSTT1 and GSTP1) and relate them to observed changes in CVD risk.


Enrollment: 48
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Broccoli
Standard Broccoli
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.
Experimental: High Glucosinolate Broccoli
High Glucosinolate Broccoli
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.
Experimental: Peas
Peas
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged ≥ 50 years will be recruited onto the study using the JBS 2 cardiac risk assessor calculator (Copyright University of Manchester 1998): Scores of 10-20% will be acceptable for participation in the study.
  • Total cholesterol ≥ 5.0mmol/L
  • Blood pressure measurements

    • Systolic≥ 120mmHg
    • Diastolic ≥ 80mmHg
    • BMI ≥20
    • Smokers and Non Smokers

Exclusion Criteria:

  • Diagnosed diabetics;
  • Fasting glucose >6mmol/L;
  • Blood pressure <90/50 or 95/55 if symptomatic; >160/100
  • Chronic kidney disease;
  • Those on any lipid lowering therapies like statins, bile acid sequestrants, cholesterol absorption inhibitors and nicotinic acid;
  • Those who have suffered a cardiovascular event like stroke, myocardial infarction or trans ischemic attacks;
  • Peripheral vascular disease including Claudication
  • Consumption of fish oil supplements (unless volunteer is willing to discontinue their use 4 weeks prior to the start of the)
  • Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/materials
  • Any person related or living with any member of the study team
  • Participation in another research project which involves blood sampling within the last four months; Blood from both studies should not exceed 470mL
  • BMI <20
  • BMI >40
  • Fasting total cholesterol > 8.0mmol/L
  • Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated
  • Going on holiday for more than 7 days in any single period or within 2 weeks of their clinical appointment at the CRTU
  • Currently suffering from or have suffered from any neck and throat injuries and surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114399


Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
University of East Anglia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Quadram Institute
ClinicalTrials.gov Identifier: NCT01114399     History of Changes
Other Study ID Numbers: 2009IFR01
First Submitted: April 27, 2010
First Posted: May 3, 2010
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Quadram Institute:
Cardiovascular Disease
Cardiovascular Disease risk (mild to moderate)
Cholesterol
Ambulatory blood pressure
Arterial Stiffness

Additional relevant MeSH terms:
Cardiovascular Diseases