Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Identification of changes in endothelial function in response to dietary modification
研究概览
简要总结
This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with peripheral arterial disease. The investigators hypothesis that a diet containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day provides flavonoid compounds that improve cardiovascular health by increasing the levels of serum adiponectin is based on evidence from the literature that indicates flavonoids present in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.
详细描述
Objectives:
- Correlate serum adiponectin levels with daily intake of pulses in individuals with peripheral arterial disease
- Monitor changes in arterial stiffness and endothelial dysfunction in individuals with early stage cardiovascular disease
- Determine the tolerability of daily consumption of pulses in the targeted population
- Identify changes in the expression profile of white blood cells.
Study Duration: 12 months
Study Design:
- This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with arterial disease
- Each subject will undergo a 7-day adaptation period consisting of a consumption of ¼ cup of pulses per serving daily, followed by a minimum of ½ cup of pulses per serving daily
- Total duration of subject participation is 8 weeks;
- Subjects will be asked to attend 3 in-person clinic visits over the duration of their participation in the study for screening, registration/baseline and end of study assessments
- Telephone follow-up to subjects will occur at weeks 1,2,4, and 6
- Both clinical assessment and subject-based data will be collected at various points of the study schedule
- Subjects will be asked to complete a food frequency questionnaire at the outset, maintain a 3-day food record at two separate occasions, and undergo a brief semi-structured interview during the telephone follow-up assessments of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 and asymptomatic carotid stenosis lesion of > 50%
- •Male or female (> 40 years of age)
- •Willing to comply with the protocol requirements
- •Willing to provide informed consent
- •Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks)
排除标准
- •Renal failure requiring dialysis
- •Currently smoking
- •Hormone replacement therapy
- •Inability to adhere to a regular diet
- •Additional intake of pulses outside the planned daily requirements outlined in the study
- •History of gastrointestinal reactions or allergies to pulses
结局指标
主要结局
Identification of changes in endothelial function in response to dietary modification
时间窗: baseline, week 8
Correlation of serum adiponectin levels
时间窗: baseline, week 8
Correlation of changes in endothelial cell function with serum isoflavone levels
时间窗: baseline, week 8
Genetic Profiling
时间窗: baseline, week 8
Analysis of serum and urinary eicosanoids
时间窗: baseline, week 8
Serum analysis for fatty acid composition
时间窗: baseline, week 8
次要结局
- Qualitative analysis of data collected from semi-structured subject interviews(week 1, week 2, week 4, week 6, week 8)
- (Compliance/tolerability/side effects)(week 1, week 2, week 4, week 6, week 8)
- Descriptive analysis of clinical data: Demographics, medical history,(baseline)
- Physical findings, concomitant medications and adverse events(baseline, weekly for 8 weeks)
研究者
Dr.Peter Zahradka
Professor, Department of Physiology
St. Boniface Hospital