The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in lipid/lipoprotein profile
研究概览
简要总结
This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation & immune function, and diet satisfaction in participants at risk for CVD.
详细描述
A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight or obese (25-35kg/m2)
- •non-smoking
- •male or female
- •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
研究组 & 干预措施
SD-Low
Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a minimal amount of spices (<1g/day for all diets).
Post prandial test meal will be contain minimal amounts of spice.
干预措施: Controlled feeding diet (Other)
SD-Mod
Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a moderate amount of spices (~3g/day in the 2100kcal diet).
Post prandial test meal will be contain a moderate amount of spice.
干预措施: Controlled feeding diet (Other)
SD-Culinary
Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a culinary dose of spices (6g/day in the 2100kcal diet).
Post prandial test meal will be contain a culinary amount of spice.
干预措施: Controlled feeding diet (Other)
结局指标
主要结局
Change in lipid/lipoprotein profile
时间窗: Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
次要结局
- Inflammation and immune fuction(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Central blood pressure(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Brachial blood pressure(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Augmentation index(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Change in Glucose(Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- HDL function(Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Diet satisfaction(After each 4 week diet period)
- Change in flow mediated dilation(Change from baseline in flow mediated dilation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Change in lipoprotein particle size and subclasses(Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Pulse wave velocity(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Change in Insulin(Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- Ambulatory blood pressure(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))
- in vitro production of inflammatory cytokines and immune markers(Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16))