Clinical trial NCT01114399: Diet and Vascular Health Study
Official title: Diet and Vascular Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular Disease
Cardiovascular Disease risk (mild to moderate)
Cholesterol
Ambulatory blood pressure
Arterial Stiffness
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: University of East Anglia
First posted: 2010-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Examination of the indicators of CVD after the consumption of broccoli, high glucosinolate broccoli and peas.
timeFrame: Week 12
Secondary outcomes:
measure: The determination of key polymorphic genes of the trial subjects
timeFrame: Baseline
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
References:
citation: 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.