Broccoli and Vascular Health Study

NCT01929564 | Completed

• 1 other identifier: IFR01/2012
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief 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

Cardiovascular Diseases

Keywords

cardiovascular disease; risk factor; broccoli; GST; blood pressure; Total cholesterol

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is to assess the change in CVD risk after a 12 week broccoli intervention by assessing the change in concentration of LDL-cholesterol on which the power calculation was based.

  The LDL cholesterol concentration (mmol/L) will be measured before and after a 12 week intervention with broccoli, using a Instrumentation Laboratories kit for use on an ILAB auto analyser.

  Baseline and 12 weeks

Secondary Outcomes (1)

• To assess the effects of the broccoli intervention clinical biomarkers of CVD. The effect of the intervention on arterial stiffness will also be measured on a sub section of the total cohort (measurements carried out on the Reading cohort).

  Baseline and 12 weeks.

Other Outcomes (1)

• To determine the genotype of the participants.

  Measurements will be made using either a pre or post intervention sample

Study Arms (2)

Beneforte broccoli

ACTIVE COMPARATOR

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

Other: Beneforte broccoli

Parthenon broccoli

PLACEBO COMPARATOR

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

Other: Parthenon Broccoli

Interventions

Beneforte broccoli OTHER

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

Beneforte broccoli

Parthenon Broccoli OTHER

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

Parthenon broccoli

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥ 50 years will be recruited onto the study using the JBS 2 cardiac risk assessor calculator.
• Scores of 10%-30% will be acceptable for participation in the study.

You may not qualify if:

• Those unable to give written informed consent
• Those unwilling to provide GP details
• Those already consuming Beneforté ® broccoli, unless they are willing to discontinue consumption for 8 weeks prior to starting the study.
• Diagnosed diabetics
• Fasting glucose \>7mmol/L (WHO guidelines for diabetics)
• Blood pressure \<90/50 or 95/55 if symptomatic; \>160/100
• Chronic kidney disease
• BMI \<20
• BMI \>40
• Fasting total cholesterol \> 8.0mmol/L
• Fasting glucose \>7mmol/L (WHO guidelines for diabetics)
• Blood pressure \<90/50 or 95/55 if symptomatic; \>160/100
• Chronic kidney disease
• BMI \<20
• BMI \>40

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Biotechnology and Biological Sciences Research Council: collaborator
• Technology Strategy Board, United Kingdom: collaborator
• Monsanto Company, LLC: collaborator
• University of Reading: collaborator

Study Sites (2)

University of Reading

Reading, Berkshire, RG6 6AH, United Kingdom

Location

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Richard Mithen, Professor

  Quadram Institute Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: August 28, 2013
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

GB (2)