Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Flow Mediated Dilation
研究概览
简要总结
A randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
详细描述
A randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. Participants will be randomized to pecans or control for 12-weeks. Outcome assessments will be measured at baseline and 12-weeks.
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
- 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 25-40 kg/m2
- •≥ 1 criterion for metabolic syndrome (i.e., waist circumference ≥ 94 cm men or ≥ 80 cm women; triglycerides ≥150 mg/dL; HDL-cholesterol ≤ 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
排除标准
- •Current use of tobacco-containing products or (≤6 months) cessation
- •Allergy/sensitivity/intolerance/dislike of study foods
- •Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
- •Individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis.
- •Type 1 or type 2 diabetes
- •Unstable weight ≥10% body weight for 6 months prior to enrollment
- •Systolic Blood pressure >160 mmHg for systolic pressure and/or diastolic blood pressure >/100 mmHg for diastolic pressure at screening
- •Fasting blood glucose ≥126 mg/dL at screening
- •Triglycerides ≥350 mg/dL at screening
- •Taking any medications known to affect lipids, blood pressure, or blood glucose levels
- •Diagnosed inflammatory conditions or taking prescribed , taking any chronic anti-inflammatory medications (>1 time per week over the past 3 months)
- •Use of antibiotics within the prior 8 weeks
- •Taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals known to affect study outcomes and not willing to cease for the duration of the study
- •Individuals consuming >14 alcoholic drinks/week, and not willing to avoid alcohol consumption for 48 hours prior to test visit
- •Pre-menopausal women who do not have a regular menstrual cycle of 25-35 days
- •PI discretion
研究组 & 干预措施
Pecan Group
Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack
干预措施: Pecans (Drug)
Usual Care Group
Participants will consume their usual diet devoid of nuts
干预措施: Usual Care (Other)
结局指标
主要结局
Flow Mediated Dilation
时间窗: 12 weeks
Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter
次要结局
- Triglycerides(12 weeks)
- Brachial Systolic and Diastolic Blood Pressure(12 weeks)
- LDL-cholesterol Concentration(12 weeks)
- HDL-cholesterol Concentration(12 weeks)
- HDL Lipoprotein Subclasses(12 weeks)
- LDL Lipoprotein Subclasses(12 weeks)
- HbA1c(12-weeks)
- Total Cholesterol Concentration(12-weeks)
- LDL Subclasses(12 weeks)
- HDL Subclass-Large(12 weeks)
- Central Systolic and Diastolic Blood Pressure(12 weeks)
- Carotid-femoral Pulse Wave Velocity(12 weeks)
- Augmentation Index@75bpm(12 weeks)
- Fasting Plasma Glucose Concentration(12 weeks)
- Serum Insulin Concentration(12 weeks)
- Diet Quality: Healthy Eating Index 2020(12-weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University