Diet and Vascular Health Study

Cardiovascular Disease Clinical Trial

— BROCCOLI  

Official title:

Diet and Vascular Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114399
• Other study ID #: 2009IFR01
• Status: Completed
• Phase: N/A
• First received: April 27, 2010
• Last updated: July 28, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Food Research	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the indicators of CVD after the consumption of broccoli, high glucosinolate broccoli and peas.	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	Week 12	No
Secondary	The determination of key polymorphic genes of the trial subjects	To determine the genotype of individuals for key polymorphic genes (GSTM1, GSTT1 and GSTP1) and relate them to observed changes in CVD risk.	Baseline	No