Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Flow mediated dilation
研究概览
简要总结
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
详细描述
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥25 and ≤40 kg/m2
- •≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
- •non-smoking
排除标准
- •Current tobacco use or use within the previous 6 months
- •Diagnosed diabetes or fasting glucose levels > 126 mg/dL at screening
- •Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg at screening.
- •Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
- •History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
- •Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
- •Pregnancy, lactation or planning to become pregnant
- •Consumption of >14 alcoholic drinks/week
- •Intolerance/allergy/sensitivity to foods included in the study menus
研究组 & 干预措施
Average American Diet
Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.
干预措施: Average American Diet devoid of nuts (Other)
Average American Diet + Pecans
Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans.
干预措施: Pecan (Drug)
Healthy Diet + Pecans
High diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans.
干预措施: Pecan (Drug)
结局指标
主要结局
Flow mediated dilation
时间窗: 4 weeks
Measured by brachial ultrasound and expressed as percent artery dilation
次要结局
- Serum insulin concentration(4 weeks)
- LDL-cholesterol concentration(4 weeks)
- HDL-cholesterol concentrations(4 weeks)
- Triglycerides(4 weeks)
- LDL lipoprotein subclasses(4 weeks)
- Peripheral systolic and diastolic blood pressure(4 weeks)
- Central systolic and diastolic blood pressure(4 weeks)
- HDL lipoprotein subclasses(4 weeks)
- Carotid-femoral pulse wave velocity(4 weeks)
- Augmentation Index(4 weeks)
- Fasting plasma glucose concentration(4 weeks)