The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose concentration
研究概览
简要总结
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.
详细描述
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥25 and ≤45 kg/m2
- •Fasting plasma glucose 100 - 125 mg/dL
- •non-Smoking
排除标准
- •Diagnosed diabetes or fasting glucose >126 mg/dl
- •Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- •Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- •Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- •Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
- •Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
- •Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
- •Smoking or use of any tobacco products
- •Allergy/intolerance/sensitive to pistachios
- •Consumption of >14 alcoholic drinks/week
- •Shift-workers and those who cannot consume a snack in the evening
研究组 & 干预措施
Evening Pistachio Consumption
Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).
干预措施: Pistachio (Drug)
Usual care
Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose.
干预措施: Usual care (Other)
结局指标
主要结局
Fasting plasma glucose concentration
时间窗: 12 weeks
Fasting blood glucose (mg/dL)
次要结局
- LDL cholesterol concentration (mg/dL)(12 weeks)
- Central systolic and diastolic blood pressure (mm Hg)(12 weeks)
- Peripheral systolic and diastolic blood pressure (mm Hg)(12 weeks)
- Serum insulin concentration (mIU/L)(12 weeks)
- Carotid-femoral pulse wave velocity (m/s)(12 weeks)
- body weight (lbs)(12 weeks)
- Diet quality: Healthy Eating Index 2015(12 weeks)
- Change in the composition of the gut microbiome(12 weeks)
- waist circumference (cm)(12 weeks)
- HbA1c(12 weeks)
- Augmentation Index (%)(12 weeks)
- HOMA-IR(12 weeks)
- HDL cholesterol concentration(12 weeks)
- Total cholesterol concentration(12 weeks)
- Triglyceride concentration(12 weeks)