Broccoli and Vascular Health Study
NCT01929564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2014-07-29
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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