Effect of Increased Whole Apple Consumption, Apple Extract and Freeze-dried Apple Products on Biomarkers of Cardiovascular Disease Risk: a Randomised Intervention in Participants at Increased Risk of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Between group change in oxidised-LDL
研究概览
简要总结
This study will examine if health benefits of consuming nutrient-rich apples, an apple extract and freeze dried apple product will be similar. 50 volunteers at increased risk of heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten participants per group, randomly assigned). Apart from the extract group, all volunteers will consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other than what has been provided by the research team. Volunteers will complete food diaries at the start and end of the study and a number of questionnaires. Blood and urine samples collected at 0 and 4 weeks
详细描述
Many products (such as bioactive extracts) attempt to replicate health benefits of a diet rich in fruit and vegetables, however, it is not known whether similar health benefits can be gained from consuming these processed products. A placebo-controlled intervention study will examine if health benefits are similar between products. Volunteers will have one risk factor for heart disease. Recruitment will be by advertisement from QUB and general public. Apples/apple products will be provided for the 4 weeks, but otherwise volunteers' normal diet and lifestyle will be followed. Blood and urine samples will be collected at week 0 and week 4. 4-day food diaries will be completed at the start and end of the study. A number of questionnaires (physical activity, lifestyle, levels of liking, tolerability to study products, study evaluation) will be completed at the start and end of the study. As this is a pilot study, power calculations were not considered appropriate. Statistical analysis will be carried out in SPSS, each endpoint of interest from the week 0 measure will be compared between the five intervention groups by one way analysis of variance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 50 years old or
- •Current Smoker or
- •Systolic Blood Pressure 120-139mmHg/ Diastolic Blood Pressure 80-89mmHg or
- •Total Cholesterol >5.2mmol/l or HDL cholesterol <1.03mmol/l or
- •BMI >25 kg/m2
排除标准
- •Diabetes mellitus
- •An acute coronary syndrome or transient ischaemic attack within the past 3 months
- •Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
- •Oral anticoagulation therapy
- •BMI >35 kg/m2
- •Excessive alcohol consumption (>28 U/week men or >21 U/week women)
- •Pregnancy/ lactation
- •Taking antioxidant supplements
- •Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
结局指标
主要结局
Between group change in oxidised-LDL
时间窗: Weeks 0 and 4
次要结局
- Between group change in biochemical markers of nutritional status(Weeks 0 and 4)
- Between group change in self-reported apple or apple product intake(Weeks 0 and 4)
- Between group change in other biomarkers of cardiovascular disease risk(Weeks 0 and 4)
- Between group change in biomarkers of cardiovascular disease risk(Weeks 0 and 4)
研究者
Jayne Woodside, PhD
Reader
Queen's University, Belfast