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Completed

NCT Number: NCT01114399

Diet and Vascular Health Study

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet and Vascular Health

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Collaborators

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

Registry information

Acronym: BROCCOLI

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 3, 2010
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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