A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in serum lipoprotein(a)
研究概览
简要总结
This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk.
详细描述
Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary therapies and its concentration is thought to be determined by genes. A plant-based diet has not been previously used in an attempt to influence the concentration of Lp(a).
Participants were instructed to follow a defined, plant-based dietary intervention for four weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits.
Serum biomarkers were obtained from participants at baseline and after 4-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≥25.0 kg/m^2
- •Serum low-density lipoprotein cholesterol concentration ≥100
- •Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90
排除标准
- •Tobacco use
- •Drug abuse
- •Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman)
- •Current cancer diagnosis
- •Estimated glomerular filtration rate <60 mg/dL
- •Clinically defined infection
- •Mental disability
- •Hospitalization <6 months
- •Previous exposure to plant-based diet
结局指标
主要结局
Change in serum lipoprotein(a)
时间窗: Baseline and 4-weeks
Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks
次要结局
- Change in serum total cholesterol(Baseline and 4-weeks)
- Change in serum low-density lipoprotein cholesterol(Baseline and 4-weeks)
- Change in serum high-density lipoprotein cholesterol(Baseline and 4-weeks)
- Change in serum high-density lipoprotein 2 cholesterol(Baseline and 4-weeks)
- Change in serum small-dense low-density lipoprotein cholesterol(Baseline and 4-weeks)
- Change in serum apolipoprotein A-1(Baseline and 4-weeks)
- Change in serum apolipoprotein-B(Baseline and 4-weeks)
- Change in serum low-density lipoprotein particles(Baseline and 4-weeks)
研究者
Rami Najjar
Principal Investigator
Texas Woman's University