Broccoli and Vascular Health Study

NCT01929564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2014-07-29

No results posted yet for this study

Summary

The participants of this study will be men \& women ≥50 years who are deemed to have a 10-30% risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise algorithm. This takes into account the participants age, sex, cholesterol values, blood pressure,family history and their ethnicity (SE Asian or not). The participants will be randomly assigned to one of two groups with the aid of a computer program called "minim" which uses their age, sex, BMI and smoking status to determine which broccoli each participant will consume on the intervention.

Each participant will consume 4 x 100g of their assigned broccoli, each week for 12 weeks on top of their normal diet. They will be allowed to eat the broccoli whenever they want during the week, but will be asked to note down when they eat it. A steamer will be provided so participants can cook their broccoli for the required 4-5 minutes. Participants will be asked to keep two diet diaries during their time on the intervention, one before they start the intervention and one towards the end. Blood samples and urine will also be collected, pre and post intervention, for the analysis of biomarkers of CVD.

This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich and the University of Reading(UoR), in Reading. Samples from the participants at both sites will be analysed at IFR, UoR and companies in the United States.

Conditions

Interventions

OTHER

Beneforte broccoli

Four x 100g portions of Beneforte broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet

OTHER

Parthenon Broccoli

Four x 100g portions of Parthenon broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet

Sponsors & Collaborators

  • Biotechnology and Biological Sciences Research Council

    collaborator OTHER
  • Technology Strategy Board, United Kingdom

    collaborator OTHER
  • Monsanto Company, LLC

    collaborator INDUSTRY
  • University of Reading

    collaborator OTHER
  • Quadram Institute Bioscience

    lead OTHER

Principal Investigators

  • Richard Mithen, Professor · Quadram Institute Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929564 on ClinicalTrials.gov