Effects of Almond Intake on Atherogenic Lipoprotein Particles
Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.
Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.
The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.
This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).
We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Berkeley、California、美国、94705
- Cholesterol Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 20 or older
- Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
- Fasting blood sugar (FBS) < 126 mg/dl
- Weight stable for > 3 months.
Exclusion Criteria:
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
- Body mass index (BMI) > 38 kg/m2
- User of nicotine products or recreational drugs
- Refusal to abstain from alcohol or dietary supplements during the study.
- Total- and LDL-C > 95th percentile for sex and age.
- Fasting triglycerides > 50mg/dl and > 500 mg/dl
- Abnormal thyroid stimulating hormone (TSH) levels.
- Pregnant or breast-feeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Standard Reference Diet
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50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
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实验性的:Almond Supplemented Diet
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50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
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有源比较器:Low Carbohydrate Reference Diet
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26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Total and LDL cholesterol
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in total and LDL cholesterol between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in small and medium LDL particles
大体时间:3 weeks, 8 weeks, and 13 weeks
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Change in small and medium LDL particles between each of the 3 test diets
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3 weeks, 8 weeks, and 13 weeks
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Change in apolipoprotein B
大体时间:3 weeks, 8 week, 13 weeks
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Change in apolipoprotein B between each of the 3 test diets
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3 weeks, 8 week, 13 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in total/HDL-cholesterol ratio
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in total/HDL-cholesterol ratio between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in LDL peak particle diameter
大体时间:3 weeks, 8 week, 13 weeks
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Change in LDL peak particle diameter between each of the 3 test diets
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3 weeks, 8 week, 13 weeks
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Change in plasma triglycerides
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in plasma triglycerides between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in HDL-cholesterol
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in HDL-cholesterol between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in large HDL particles
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in large HDL particles between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in apolipoprotein AI
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in apolipoprotein AI between each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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Change in HOMA-IR
大体时间:3 weeks, 8 weeks, 13 weeks
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Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
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3 weeks, 8 weeks, 13 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Standard reference diet的临床试验
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