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临床试验/NCT01792648
NCT01792648已完成不适用

Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity

UCSF Benioff Children's Hospital Oakland1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in apolipoprotein B

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Standard Reference Diet

Active Comparator

干预措施: Standard reference diet (Other)

Almond Supplemented Diet

Experimental

干预措施: Almond supplemented diet (Other)

Low Carbohydrate Reference Diet

Active Comparator

干预措施: Low carbohydrate reference diet (Other)

结局指标

主要结局

Change in apolipoprotein B

时间窗: 3 weeks, 8 week, 13 weeks

Change in apolipoprotein B between each of the 3 test diets

Change in Total and LDL cholesterol

时间窗: 3 weeks, 8 weeks, 13 weeks

Change in total and LDL cholesterol between each of the 3 test diets

Change in small and medium LDL particles

时间窗: 3 weeks, 8 weeks, and 13 weeks

Change in small and medium LDL particles between each of the 3 test diets

次要结局

  • Change in total/HDL-cholesterol ratio(3 weeks, 8 weeks, 13 weeks)
  • Change in plasma triglycerides(3 weeks, 8 weeks, 13 weeks)
  • Change in LDL peak particle diameter(3 weeks, 8 week, 13 weeks)
  • Change in HDL-cholesterol(3 weeks, 8 weeks, 13 weeks)
  • Change in HOMA-IR(3 weeks, 8 weeks, 13 weeks)
  • Change in large HDL particles(3 weeks, 8 weeks, 13 weeks)
  • Change in apolipoprotein AI(3 weeks, 8 weeks, 13 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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