The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in flow mediated dilation
研究概览
简要总结
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.
详细描述
A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.
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 (Outcomes Assessor)
盲法说明
Person assessing the outcome measures will be blinded to participant allocation
入排标准
- 年龄范围
- 30 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 Overweight or obese (25-35kg/m2) Non-smoking Waist circumference >= 94cm for men and >=80cm for women
- •At least one other of the following:
- •LDL- cholesterol >130mg/dL
- •CRP >1mg/L
- •Triglycerides >=150mg/dL
- •HDL <40mg/dL for men or <50mg/dL for women
- •Systolic blood pressure >= 130mmHg or diastolic >= 85mmHg
- •Fasting glucose >=100mg/dL
排除标准
- •Diabetes (fasting glucose >126mg/dL)
- •Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- •Prescribed anti-hypertensive or glucose lowering drugs
- •Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
- •Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
- •Pregnancy or lactation
- •Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
- •Vegetarianism
结局指标
主要结局
Change in flow mediated dilation
时间窗: Change from baseline at 2 hours and 4 hours after meal consumption
Endothelial function measured by FMD
次要结局
- Insulin(Change from baseline during the 4 hours after meal consumption)
- Inflammatory cytokines in isolated peripheral blood mononuclear cells(Change from baseline during the 4 hours after meal consumption)
- Lipid and lipoproteins(Change from baseline during the 4 hours after meal consumption)
- Plasma Inflammatory cytokines(Change from baseline during the 4 hours after meal consumption)
- Glucose(Change from baseline during the 4 hours after meal consumption)
- Plasma antioxidants(Change from baseline during the 4 hours after meal consumption)