Effects of a Diet Rich in Almonds on LDL Cholesterol, LDL Particle Size, Abdominal Adiposity and Vascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Lipid/lipoprotein profile
研究概览
简要总结
The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI (20-35)
- •Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)
排除标准
- •Pregnant, planning to become pregnant, or lactating
- •Smoking; cholesterol-lowering medication
- •Glucose-lowering medication
- •Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen)
- •The following medical conditions:
- •heart disease
- •Heart attack
- •blood pressure >140/90
- •renal or kidney disease
- •rheumatoid arthritis
- •blood clotting disorder
- •liver disease or cirrhosis
- •compromised immune system
- •peripheral vascular disease or circulation problems
- •*> 10% body weight loss in the past 6 months
- •vegetarian
- •nut allergies
结局指标
主要结局
Lipid/lipoprotein profile
时间窗: End of diet period 1 (week 6) and diet period 2 (week 14)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides are measured as part of the lipoprotein profile. Diet period one runs for 6 weeks, then there is a 2 week compliance break, and then diet period two runs for 6 weeks (total time commitment is 14 weeks).
次要结局
- HDL functionality (cholesterol efflux)(End of diet period 1 (week 6) and diet period 2 (week 14))
- Cholesterol absorption/synthesis (measured by plasma plant sterols and cholesterol precursors)(End of diet period 1 (week 6) and diet period 2 (week 14))
- Waist circumference(End of diet period 1 (week 6) and diet period 2 (week 14))
- Additional lipid/lipoprotein measures (VLDL, IDL, and remnant lipoproteins)(End of diet period 1 (week 6) and diet period 2 (week 14))
- Lipoprotein (LDL, HDL, VLDL, IDL) subclasses(End of diet period 1 (week 6) and diet period 2 (week 14))
- Leg adiposity as measured by dual-energy x-ray absorptiometry(End of diet period 1 (week 6) and diet period 2 (week 14))
- Abdominal adiposity as measured by dual-energy x-ray absorptiometry(End of diet period 1 (week 6) and diet period 2 (week 14))
- Apolipoproteins (A1 and B)(End of diet period 1 (week 6) and diet period 2 (week 14))
- Vascular health (plasma nitric oxide)(End of diet period 1 (week 6) and diet period 2 (week 14))
- Total body composition as measured by dual-energy x-ray absorptiometry(End of diet period 1 (week 6) and diet period 2 (week 14))