Efficacy of Almonds Added to Chronic Statin Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Measure of lipid panel including subfractions and Lp(a) and almond adherence
研究概览
简要总结
The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾ cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study will compare the effects on the lipoprotein profile to patients who eat almonds and those patients not eating almonds.
详细描述
The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol], LDL-C particle size, and the emerging risk factor Lp(a) when 100-110 g of almonds daily are added to statin therapy. Also, all subjects will receive Step I dietary counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable on current statin regimen for at least 8 weeks with plans to continue on the same dose while participating in the study
- •Male or non-pregnant female - Women are eligible if they are surgically sterile or postmenopausal not using hormone replacement therapy (HRT) or using a stable, consistent does of HRT with intentions to continue therapy throughout the course of the study. Females of childbearing potential are eligible if using an effective form or contraception and intention to continue use through the study
- •Mentally competent to understand study
- •Speak and read English
- •Able to maintain current medication regimen throughout study duration
排除标准
- •LDL-C levels <70mg/dL
- •Currently taking lipid-lowering agents other than statins including niacin, bile-acid sequestrants, ezetimibe, fibrates, high-dose Omega-3 fish oils (>1500mg of combined EPA/DHA daily) and policosanol
- •Adherence to specialized diet regimes, i.e., multiple food allergies or nut allergy, vegetarian, macrobiotic, fad or popular diets, taking diet pills, etc.
- •Already consuming nuts more than twice a week
- •Active liver disease or a history of liver disease
- •Chronic disease involving, hepatic, renal or coronary artery disease
- •Currently taking systemic steroidal drugs
- •Dependence on alcohol (> 10 drinks per week) or illicit drugs
- •Participation in any other clinical trial within the last 30 days
- •Engages in moderate intensity exercise for > 30 minutes each day
- •Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study
结局指标
主要结局
Measure of lipid panel including subfractions and Lp(a) and almond adherence
时间窗: Once a month
次要结局
- Measurement of height, weight, waist circumference, blood pressure and physical activity(Once a month)
研究者
Janelle Ruisinger, PharmD
Clinical Associate Professor
University of Kansas