Diet and Vascular Health Study (BROCCOLI)

• ClinicalTrials.gov Identifier: NCT01114399
• Recruitment Status: Completed
• First Posted: May 3, 2010
• Last Update Posted: July 29, 2014
• Sponsor: Quadram Institute Bioscience
• Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK); University of East Anglia
• Information provided by (Responsible Party): Quadram Institute Bioscience

Tracking Information

• First Submitted Date: April 27, 2010
• First Posted Date: May 3, 2010
• Last Update Posted Date: July 29, 2014
• Study Start Date: January 2010
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2010)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 30, 2010)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diet and Vascular Health Study
• Official Title: Diet and Vascular Health Study
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Cardiovascular Disease

Intervention

• 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.

Study Arms

• Experimental: Standard Broccoli
  Standard Broccoli
  Intervention: Dietary Supplement: Diet and Vascular Health
• Experimental: High Glucosinolate Broccoli
  High Glucosinolate Broccoli
  Intervention: Dietary Supplement: Diet and Vascular Health
• Experimental: Peas
  Peas
  Intervention: Dietary Supplement: Diet and Vascular Health Study

• Publications *: Armah CN, Traka MH, Dainty JR, Defernez M, Janssens A, Leung W, Doleman JF, Potter JF, Mithen RF. A diet rich in high-glucoraphanin broccoli interacts with genotype to reduce discordance in plasma metabolite profiles by modulating mitochondrial function. Am J Clin Nutr. 2013 Sep;98(3):712-22. doi: 10.3945/ajcn.113.065235.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2014): 48
• Original Estimated Enrollment (submitted: April 30, 2010): 54
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01114399
• Other Study ID Numbers: 2009IFR01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Quadram Institute Bioscience
• Original Responsible Party: Professor Richard Mithen, Institute of Food Research
• Current Study Sponsor: Quadram Institute Bioscience
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: Quadram Institute Bioscience
• Verification Date: July 2014