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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Diet and Vascular Health |
| ISRCTN | ISRCTN20997112 |
| ClinicalTrials.gov identifier | |
| Public title | Diet and Vascular Health |
| Scientific title | The effects of a diet rich in broccoli on cardiovascular disease risk in adults: a randomised interventional prevention trial |
| Acronym | N/A |
| Serial number at source | 7740 |
| Study hypothesis | The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular disease risk using biochemical indicators such as blood lipid profiles, most notably cholesterol; markers of inflammation as well as established physiological measurements such as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure Measurements (ABPM). Broccoli contains compounds know as glucosinolates which are metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought to be the principal component in broccoli that may reduce CVD risk. We will use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates (‘HG broccoli’). This broccoli has been used in previous intervention studies (e.g. ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the broccoli) parallel study. The volunteers recruited will, according to the Joint British Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or having a cardiovascular (CV) event in the next 10 years. |
| Lay summary | |
| Ethics approval | Hertfordshire Research Ethics Committee (REC) approved on the 7th October 2009 (ref: 09/H0311/96) |
| Study design | Randomised interventional prevention trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Primary Care Research Network for England, Cardiovascular; Subtopic: Not Assigned, Cardiovascular (all Subtopics); Disease: Cardiovascular, All Diseases |
| Participants - inclusion criteria |
1. Men and women aged greater than or equal to 50 years
2. Recruited onto the study using the JBS cardiac risk assessor calculator. Scores of 1020% will be acceptable for participation in the study. 3. Total cholesterol greater than or equal to 5.0 mmol/L 4. Blood pressure measurements: systolic greater than or equal to 120 mmHg, diastolic greater than or equal to 80 mmHg 5. Body mass index (BMI) greater than 20 kg/m^2 |
| Participants - exclusion criteria |
1. Diagnosed diabetics
2. Fasting glucose greater than 6 mmol/L 3. Blood pressure less than 90/50 mmHg or 95/95 mmHg if symptomatic; greater than 160/100 mmHg 4. Chronic kidney disease 5. Those on hypolipidemic therapy 6. Those who have suffered a cardiovascular event like stroke, myocardial infarction, trans ischemic attacks etc within 2 years 8. Peripheral vascular disease including claudication 9. Consumption of fish oil supplements (unless volunteer is willing to discontinue their use at least 4 weeks prior to intervention starting) 10. Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/materials 11. Any person related or living with any member of the study team 12. Participation in another research project which involves blood sampling within the last four months; blood from both studies should not exceed 470 mL 13. BMI less than 20 kg/m^2 or BMI greater than 40 kg/m^2 14. Fasting total cholesterol greater than 8.0 mmol/L 15. Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated 16. Going on holiday for more than 7 days in any single period or within 2 weeks of their clinical appointment at the CRTU 17. Currently suffering from or have suffered from any neck and throat injuries and surgery |
| Anticipated start date | 04/01/2010 |
| Anticipated end date | 31/08/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned Sample Size: 54; UK Sample Size: 54 |
| Interventions |
The volunteers will be matched for gender while being assigned to one of 3 study groups:
1. One group will consume 400 g of standard broccoli each week for 12 weeks 2. The second group will consume 400 g of the high glucosinolate broccoli each week for 12 weeks 3. The third group will consume 400 g of peas each week for 12 weeks The broccoli and the peas will be consumed on top of the volunteer's standard diet. Once the volunteers have completed their final visit to the CRTU after 12 weeks of the intervention, there will be no further contact. Study entry: single randomisation only |
| Primary outcome measure(s) | Cholesterol, measured at baseline and week 12 |
| Secondary outcome measure(s) | Genotyping, measured at baseline |
| Sources of funding | Biotechnology and Biological Science Research Council (BBSRC) (UK) (ref: IFR/08/4) |
| Trial website | |
| Publications | |
| Contact name | Dr Charlotte Armah |
| Address |
Institute of Food Research
Colney Lane Colney |
| City/town | Norwich |
| Zip/Postcode | NR4 7UA |
| Country | United Kingdom |
| Sponsor | Institute of Food Research (UK) |
| Address |
Norwich Research Park
Colney |
| City/town | Norwich |
| Zip/Postcode | NR4 7UA |
| Country | United Kingdom |
| Sponsor website: | http://www.ifr.ac.uk/ |
| Date applied | 29/04/2010 |
| Last edited | 29/04/2010 |
| Date ISRCTN assigned | 29/04/2010 |
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