CClinicalTrials.gg
CompletedNCT01114399BROCCOLIUpdated Jul 29, 2014

Diet and Vascular Health Study

An interventional study of Diet and Vascular Health and Diet and Vascular Health in Cardiovascular Disease, sponsored by Quadram Institute Bioscience. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Cardiovascular Disease
  • Cardiovascular Disease risk (mild to moderate)
  • Cholesterol
  • Ambulatory blood pressure
  • Arterial Stiffness
03

In context

Cardiovascular Diseases

4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 48 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Quadram Institute Bioscience is the lead sponsor of 42 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Standard Broccoli

    Standard Broccoli

    Dietary Supplement: Diet and Vascular Health

  • Experimental
    High Glucosinolate Broccoli

    High Glucosinolate Broccoli

    Dietary Supplement: Diet and Vascular Health

  • Experimental
    Peas

    Peas

    Dietary Supplement: Diet and Vascular Health Study

Interventions

  • Dietary supplementDiet 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 supplementDiet 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 supplementDiet 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Institute of Food Research
    Norwich, Norfolk NR4 7UA, United Kingdom
08

References and documents

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. PubMed 23964055 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01114399
Lead sponsor
Quadram Institute Bioscience
Collaborators
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), University of East Anglia
Responsible party
Sponsor
First posted
May 3, 2010
Start date
Jan 2010
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jul 29, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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