A Randomized, Controlled-Feeding, Crossover Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Change in LDL-C concentration measured in blood
研究概览
简要总结
This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.
详细描述
This trial will utilize a randomized, two-period crossover design to examine the effects of cashew consumption on LDL-C and other aspects of the fasting lipoprotein lipid profile in healthy, moderately hyper-cholesterolemic individuals consuming a typical "American diet." Two arms consisting of two 28-day controlled-feeding treatment periods will allow for an isocaloric comparison of a diet with or without cashews.
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
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of ≥18.00 and ≤32.00 kg/m^2
- •Fasting LDL-C level ≥130 mg/dL and <200 mg/dL
- •Fasting TG ≤350 mg/dL
排除标准
- •CHD or CHD risk equivalent
- •Pregnancy
- •Use of lipid altering medications which cannot be stopped
- •Certain liver, kidney, lung, or gastrointestinal conditions
- •Poorly controlled hypertension
- •Certain medications
- •Allergy or sensitivity to nuts or other food/beverage or food/beverage component
- •Active cancers treated within prior 2 years (except non-melanoma skin cancer)
- •Significant weight loss or gain within prior 3 months
研究组 & 干预措施
Crossover 1: Control Diet followed by Active Diet
Treatment Period 1: Controlled diet without cashew nuts; Treatment Period 2: Controlled diet with cashew nuts
干预措施: Control followed by Cashews (Other)
Crossover 2: Active Diet followed by Control Diet
Treatment Period 1: Controlled diet with cashew nuts; Treatment Period 2: Controlled diet without cashew nuts
干预措施: Cashews followed by Control (Other)
结局指标
主要结局
Change in LDL-C concentration measured in blood
时间窗: % change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.
次要结局
- Total cholesterol change(% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.)
- HDL-cholesterol change(% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.)
- Non-HDL-cholesterol change(% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.)
- Triglyceride change(% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.)
- Total cholesterol/HDL-cholesterol ratio change(% change from baseline (day 0) to the end of the test period (day 28) for Test Period I and II.)