The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
研究概览
简要总结
Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal.
Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.
详细描述
This will be a randomized, controlled trial in men and postmenopausal women (50-75y). Subjects will be randomized into one of the two study groups: a control group (CON) following their usual diet, or intervention group (PECAN) following their usual diet but also consuming 68g/day of pecans as a snack.
There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. Subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected.
Hypothesis
Daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. Additionally, also the PECAN group will result in improved postprandial blood lipids and vascular measures compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone > 30 IU/mL) between the ages of 50-75y
- •Body mass indexes (BMI) between 18-34.9kg/m2
排除标准
- •Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- •Pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years
- •Regularly exercise more than 3 h/week
- •Weight gain or loss more than 5% of their body weight in the past 3 months
- •Plans to begin a weight loss/exercise regimen during the trial
- •Gastrointestinal surgeries, conditions or disorders
- •History of medical or surgical events that could affect swallowing
- •Chronic or metabolic diseases
- •Previous MI, stroke, or cancer
- •Fasting blood glucose levels greater than 126 mg/dL
- •Blood pressure greater than 180/120 mmHg
- •Medication use affecting digestion and absorption, metabolism
- •Lipid-lowering medications
- •Medications for diabetes, depression, or ADD/ADHD
- •Regular use of medications known to affect endothelial function or blood vessel tone
- •Blood pressure medication and steroid/hormone therapies
- •Individuals on a medically prescribed or special diet
- •Individuals with food allergies to foods specifically in the study
- •Excessively use alcohol (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- •Tobacco or nicotine use
- •Individuals taking fish oil and omega-3 fatty acid supplements
- •Significant head trauma or brain surgery
- •A score >26 on the Beck's Depression Inventory II (BDI-II)
- •A score <24 on the Mini-Mental State Examination (MMSE) will be excluded.
结局指标
主要结局
Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
时间窗: Baseline and 4 weeks
Flow-Mediated Dilation %
Change in fasting and postprandial vessel diameter from baseline to 4 weeks
时间窗: Baseline and 4 weeks
baseline diameter (mm) and peak dilation (mm)
Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks
时间窗: Baseline and 4 weeks
Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)
Change in fasting and postprandial shear rate from baseline to 4 weeks
时间窗: Baseline and 4 weeks
baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)
Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks
时间窗: Baseline and 4 weeks
O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)
次要结局
- Change in fasting blood lipids from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial hunger and satiety from baseline to 4 weeks(Baseline and 4 weeks)
- Change in baseline weight at 4 weeks(Baseline and 4 weeks)
- Change in baseline waist and hip circumference(Baseline and 4 weeks)
- Change in blood pressure from baseline to 4 weeks(Baseline and 4 weeks)
- Change in baseline total body fat percentage at 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial insulin from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial antioxidants from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting inflammation from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks(Baseline and 4 weeks)
- Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks(Baseline and 4 weeks)
研究者
Jamie Cooper, PhD
Associate Professor, Dept. of Foods and Nutrition
University of Georgia