We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 98 for:    broccoli
Previous Study | Return to List | Next Study

Broccoli and Vascular Health Study (BASH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929564
First Posted: August 28, 2013
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Biotechnology and Biological Sciences Research Council
Technology Strategy Board, United Kingdom
Monsanto Company, LLC
University of Reading
Information provided by (Responsible Party):
Quadram Institute
  Purpose

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.


Condition Intervention
Cardiovascular Diseases Other: Beneforte broccoli Other: Parthenon Broccoli

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Broccoli and Vascular Health Study

Further study details as provided by Quadram Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline and 12 weeks ]
    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.


Secondary Outcome Measures:
  • 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). [ Time Frame: Baseline and 12 weeks. ]

    The clinical biomarkers include, hs-CRP (mg/L), NEFAs(mg/dL), Plasma NO(umol/L), hs-IL6(pg/mL), TNF-α(pg/mL), ox LDL(umol/L), IL-1beta(pg/L), PCOOH(pmols/L), F-2 isoprostanes (mg/mL/mg creatine) and 8-OHdG (ng/mL).

    The effect of the intervention on arterial stiffness on a sub section of the cohort (Reading cohort)will also be measured. The first measurement will be Pulse wave velocity (m/sec); the 2nd measurement will be Laser Doppler Imaging with iontophoresis (perfusion units(area under the blood flow.time curve)).



Other Outcome Measures:
  • To determine the genotype of the participants. [ Time Frame: Measurements will be made using either a pre or post intervention sample ]
    DNA samples from all participants will be genotyped for PAPOLG (NM_022894.3) rs11687951, rs28459296 and rs7579240 and GSTM1 genotype using predesigned Invitrogen TaqMan® Assays according to manufacturers' instructions.


Enrollment: 95
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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: Beneforte broccoli
Four x 100g portions of Beneforte broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet
Placebo Comparator: Parthenon broccoli
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
Four x 100g portions of Parthenon broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Fasting total cholesterol > 8.0mmol/L
  • Haemoglobin Men <13.8g/dL (8.56mmol/L) Women <12.1g/DL (<5.51mmol/L)
  • Peri-menopausal women (defined as : when there is a change in menses)
  • Women on HRT for less than one year
  • Women who are pregnant or breastfeeding
  • Those taking self-prescribed aspirin for cardiovascular reasons
  • All those taking blood pressure medication
  • Those on any lipid lowering therapies such as statins, bile acid sequestrants, cholesterol absorption inhibitors and nicotinic acid
  • Those on regular medication for hypercoagulation and inflammatory conditions e.g. corticosteroids and asthma (intermittent use of an inhaler will be discussed on an individual basis)
  • Those on glucose lowering medications
  • Those who have ever suffered a cardiovascular event such as stroke, myocardial infarction or trans ischemic attacks
  • Peripheral vascular disease including Claudication
  • Consumption of fish oil supplements (unless participant is willing to discontinue their use 8 weeks prior to the start of the intervention- all other supplements with be dealt with on an individual basis)
  • Parallel participation in another research project which involves dietary intervention and/or sampling of blood
  • Any person related to or living with any member of the study team
  • Participation in another research project which involves blood sampling within the last four months unless the total blood from both studies (including this one) does not exceed 470mL)
  • Those who have donated or intend to donate blood within 16 weeks of the first and last study samples
  • Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated
  • Going on holiday for more than two weeks during the intervention
  • Those undergoing any on-going GP investigation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929564


Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AH
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute
Biotechnology and Biological Sciences Research Council
Technology Strategy Board, United Kingdom
Monsanto Company, LLC
University of Reading
Investigators
Study Director: Richard Mithen, Professor Quadram Institute
  More Information

Responsible Party: Quadram Institute
ClinicalTrials.gov Identifier: NCT01929564     History of Changes
Other Study ID Numbers: IFR01/2012
First Submitted: March 27, 2013
First Posted: August 28, 2013
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Quadram Institute:
cardiovascular disease
risk factor
broccoli
GST
blood pressure
Total cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases