Broccoli and Vascular Health Study (BASH)
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|ClinicalTrials.gov Identifier: NCT01929564|
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : July 29, 2014
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 or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Other: Beneforte broccoli Other: Parthenon Broccoli||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Broccoli and Vascular Health Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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
- 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.
- 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)).
- 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.
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
|University of Reading|
|Reading, Berkshire, United Kingdom, RG6 6AH|
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 7UA|
|Study Director:||Richard Mithen, Professor||Quadram Institute|