A 4-week Defined, Raw, Plant-based Diet Improves Anthropometric, Hemodynamic, and Other Cardiovascular Risk Factors
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 body weight
研究概览
简要总结
This study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.
详细描述
Plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. In addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators.
Participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. All animal products, including eggs and dairy, 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.
Participants came to a total of 4 follow-up visits. A laboratory panel was obtained at baseline and at 4-weeks. A 24-hour recall was also conducted at baseline and at 4-weeks. Anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.
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 body weight
时间窗: Baseline, follow-up weeks 1-4
Weight (kg) was documented at baseline and during 4 additional weekly follow-up visits
Change in serum low-density lipoprotein cholesterol (LDL)
时间窗: Baseline and 4-weeks
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in blood pressure
时间窗: Baseline, follow-up weeks 1-4
Systolic and diastolic blood pressure (mmHg) was documented at baseline and during 4 additional weekly follow-up visits
次要结局
- Change in heart rate(Baseline, follow-up weeks 1-4)
- Change in c-reactive protein (CRP)(Baseline and 4-weeks)
- Change in waist circumference(Baseline, follow-up weeks 1-4)
- Change in serum insulin(Baseline and 4-weeks)
- Change in serum hemoglobin A1c (HgA1c)(Baseline and 4-weeks)
- Change in serum triglycerides(Baseline and 4-weeks)
- Change in serum high-density lipoprotein cholesterol(Baseline and 4-weeks)
- Change in medication use(Baseline, follow-up weeks 1-4)
- Change in serum total cholesterol(Baseline and 4-weeks)
- Change in serum glucose(Baseline and 4-weeks)
研究者
Rami Najjar
Student
Texas Woman's University