The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Fasting Plasma Glucose
研究概览
简要总结
A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.
详细描述
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking
- •Impaired fasting glucose at screening (≥ 100 mg/dL).
- •BMI ≥20 and ≤40 kg/m2.
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
- •Pregnancy or lactation
- •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 to test foods
- •Consumption of >14 alcoholic drinks/week
研究组 & 干预措施
Evening Peanut Consumption
Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).
干预措施: Peanut (Drug)
Evening Snack
Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).
干预措施: High carbohydrate snack (Drug)
结局指标
主要结局
Fasting Plasma Glucose
时间窗: 6 weeks
Within-condition mean differences (change from baseline).
次要结局
- Fructosamine(6 weeks)
- Central Systolic and Diastolic Blood Pressure(6 weeks)
- Triglycerides(6 weeks)
- Fasting Insulin(6 weeks)
- Augmentation Index (%)(6 weeks)
- Microbiota Alpha-diversity(6 weeks)
- Peripheral Systolic and Diastolic Blood Pressure(6 weeks)
- Carotid Femoral Pulse Wave Velocity(6 weeks)
- LDL Cholesterol(6 weeks)
- Total Cholesterol(6 weeks)
- Body Weight(6 weeks)
- HDL Cholesterol(6 weeks)