Broccoli and Vascular Health Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
This intervention will take place at two independent sites, The Institute of Food Research's Human Nutrition Unit (HNU)in Norwich and the Hugh Sinclair Human Nutrition Unit (HSU), at the University of Reading. The participants recruited from Norwich and Reading will solely attend the unit in their area and the paper work has been written to reflect this i.e.separate participant information sheets (PIS). In addition to the tests carried out at both sites, the Reading cohort will also undergo additional vascular tests, also reflected in the PIS. Despite the sites being independent, 96 participants will be recruited across both sites, with the possibility of uneven numbers from each site making up the final number.
The purpose of this study is to assess whether diet can affect an individuals chances of developing CVD, as it is one of the biggest killers in the UK. We are particularly interested in participants who have a 10%-30% risk of developing CVD. We are able to assess a person's risk with the help of the Joint British Societies 2 guidelines on the prevention of cardiovascular disease, cardiovascular disease risk prediction chart. These charts take a number of parameters we obtain from the participant, their age, sex, total cholesterol concentration, systolic blood pressure (BP), body mass index (BMI), serum high density lipoprotein concentration, their smoking status and diabetes status and put them into an algorithm. The result is a risk score out of 100, of a person developing CVD over the next 10 years.
The study will be conducted over two sites, Reading and Norwich, with a principal investigator assigned to each site. The total number of participants recruited over both sites will be 96. It may be that uneven numbers are recruited over the two sites e.g. 46 at one and 50 at another however regardless of the number at each site, 48 participants will be assigned to each of the two groups. One group will consume 400g of the commercially available high glucosinolate Beneforté® broccoli each week for 12 weeks and the other will consume 400g of a standard broccoli, Parthenon for 12 weeks.
As we are assessing the effect of diet on CVD risk, our participants will be screened initially. Their urine will be tested (urine dipstick test), their height, weight, waist and hip measurements, BMI, BP will be measured and questions linked to lifestyle choices (alcohol consumption, smoking status and physical activity) will be asked. A separate section pertaining to women's health will also be present on the questionnaire.
All participants will be asked to give written informed consent before they can participate in the intervention study. The Reading cohort will be sent a copy of the consent and medical declaration forms to read through at home. The forms sent to the homes will be clearly distinguishable from the real forms as they will have the watermark with "SAMPLE" written across them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)