Effects of Pulse Varieties on Blood Vessel Function in Individuals With Peripheral Artery Disease (PAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.
研究概览
简要总结
Consumption of a diet containing pulse crops provides flavonoid compounds that will improve vascular function and glycemic control in individuals with Peripheral Artery Disease.
详细描述
This is a single site, randomized, controlled, food intervention study designed to explore the effects of pulse types and varieties on blood vessel function in individuals with Peripheral Artery Disease.
Phase One(Acute): To identify relative potency of pulse types (beans,peas, lentils,and chickpeas) for vascular activity in healthy participants and participants with Peripheral Artery Disease. Healthy participants (10) and participants with Peripheral Artery Disease (10) will be asked to consume (in random order) one test food per in-person visit over 5 visits scheduled a minimum of 6 days apart. Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
Phase Two(Chronic): Chronic 8-week study using mixed beans (pinto, kidney, black, and navy) to determine improvements in vascular function, cardiovascular risk factors, and glycemic control in participants with Peripheral Artery Disease (N=75, 25/group). Participants will be randomly assigned to one of the following three groups: i) foods containing 0.6 cup mixed beans/day consumed 5 days per week (total amount is 3 cups mixed beans per week); or, ii) foods containing 0.3 cup mixed beans/day for 5 days per week); or, iii) pulse-free foods (control) consumed 5 days/week. A total of 3 in-person visits for screening, baseline and final will be required during the 8-week study schedule. Assessments of vascular function, cognitive function, food dietary intake and preferences, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed at baseline and at 8 weeks.
Phase Three(Follow-Up: An 8-week follow-up assessment with a subset of participants (n=10/group, 3 groups) with Peripheral Artery Disease will be done at 2, 4, and at 8 weeks. Assessments of vascular function, cognitive function, food dietary intake, flavonoid levels and cardiovascular risk markers in blood and urine, glycemic control, and anthropometrics will be completed. These assessments will enable us to determine the length of time the benefits of the pulse consumption are retained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 34 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants, Acute Phase:
- •Healthy volunteers, male or female, >33 years of age, age matched with PAD participants ± 7 years;
- •BMI 18-30;
- •Glycated hemoglobin < 6.5%;
- •Fasting serum total cholesterol < 4 mmol/L and triglycerides < 2.5 mmol/L;
- •Blood pressure < 140/90 mm Hg;
- •Ankle-brachial Index (ABI) >0.9;
- •Willing to comply with the protocol requirements;
- •Willing to provide informed consent.
- •Inclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
- •Male or female, > 40 years of age;
- •Documented Peripheral Artery Disease including those with claudication as defined by an ankle brachial Index of ≤ 0.90; or asymptomatic carotid stenosis of > 50% or confirmed by imaging; or having had a previous intervention for Peripheral Artery Disease or carotid disease;
- •Stable medication profile with no changes required for the past 3 months;
- •Willing to comply with the protocol requirements;
- •Willing to provide informed consent.
排除标准
- •Healthy Participants, Acute Phase:
- •Currently smoking, or smoking within the last 6 months;
- •Clinically diagnosed disease affecting the heart, liver, kidneys, lungs, gastrointestinal, endocrine or blood/immune systems that requires medical treatment;
- •Taking any prescribed medication with the exception of birth control and hormone (estrogen) replacement therapy;
- •Pregnancy;
- •Amputation of upper or lower extremity on both sides;
- •History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods.
- •Exclusion Criteria, Participants with Peripheral Artery Disease (Acute Phase and Chronic Phase):
- •Currently smoking, or smoking within the last 6 months;
- •Type 1 diabetes;
- •Renal failure requiring dialysis;
- •Acute cardiovascular event or medical illness within the past 3 months precluding study participation;
- •Hormone (estrogen) replacement therapy;
- •Amputation of upper or lower extremity on both sides;
- •History of severe gastrointestinal reactions or allergies to pulses or ingredients used to prepare the pulse-containing and pulse-free foods;
- •Currently participating in or having participated in a food study within the last 3 months unless randomized to a control group and consumed no study foods;
- •High pulse consumption (greater or equal to 2 servings per week);
- •Inability to adhere to a regular diet;
- •Additional intake of pulses other than the requirements outlined in the study.
结局指标
主要结局
Evaluate individual pulse types and varieties in healthy participants and participants with Peripheral Artery Disease.
时间窗: 5-week schedule
Vascular responsiveness will be monitored non-invasively by peripheral arterial tonometry before consumption of the test food and 2 hours post food consumption. Blood samples will be collected at the same time intervals for analyses, of vascular, inflammatory, and metabolic markers as well as flavonoids present in the pulses.
次要结局
- Evaluate the effects of mixed beans to determine improvements in vascular function(16 weeks)
- Analysis of dietary patterns and nutritional intake, compliance and tolerability before and after consumption of an 8-week diet of mixed beans(8 weeks)
- Evaluate the effects of mixed beans on cognitive function(16 weeks)
研究者
Dr. Peter Zahradka
Professor, Department of Physiology
University of Manitoba