Diet and Vascular Health Study

Study Overview
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Brief Summary
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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.

Official Title
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Diet and Vascular Health Study

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Diet and Vascular Health
* Dietary Supplement: Diet and Vascular Health
* Dietary Supplement: Diet and Vascular Health Study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Broccoli<br>Standard Broccoli | Dietary Supplement: Diet and Vascular Health<br>* 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.<br>|
| Experimental: High Glucosinolate Broccoli<br>High Glucosinolate Broccoli | Dietary Supplement: Diet and Vascular Health<br>* 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.<br>|
| Experimental: Peas<br>Peas | Dietary Supplement: Diet and Vascular Health Study<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Disease, Cardiovascular Disease risk (mild to moderate), Cholesterol, Ambulatory blood pressure, Arterial Stiffness