Diet and Vascular Health Study (BROCCOLI)

This study has been completed.
Sponsor:
Collaborators:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
University of East Anglia
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01114399
First received: April 27, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Diet and Vascular Health Study

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Examination of the indicators of CVD after the consumption of broccoli, high glucosinolate broccoli and peas. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114399

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

No publications provided by Institute of Food Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT01114399     History of Changes
Other Study ID Numbers: 2009IFR01
Study First Received: April 27, 2010
Last Updated: July 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014