Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
研究概览
简要总结
This study will evaluate providing fruits and vegetables in a sustainable community care clinic setting, in addition to routine medical care, to individuals with CKD (Stage 2-4) on CKD and CVD risk, or cardio-renal risk factors. Further, metabolomics profiling will be used to study how change in the diet affects disease risk. Data from this study will be published in peer-reviewed journals, presented at national conferences, and will serve as pilot data to guide and strengthen applications for NIH funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate in a 3-month F&V study.
- •Positive urine dipstick (Proteinuria and/or Albumin-to-Creatinine Ratio >=10).
- •African-American (self-declared) race
- •A current diagnosis of hypertension or a current blood pressure reading consistent with hypertension (SBP >= 140 and/or DBP >=90).
- •Access to the internet via personal computer or mobile device.
- •Ability to read and write in English.
排除标准
- •Negative urine dipstick.
- •Currently receiving dialysis or needing dialysis (Stage 5 Kidney Disease)
- •Have received or need a kidney transplant.
- •Pregnant or planning to become pregnant in the next 6 months.
- •Baseline urine potassium > 60mEq/g creatinine
- •Negative diagnosis of hypertension or blood pressure reading (SBP <140 or DBP <90).
- •Nephrotic proteinuria demonstrated on urine ACR measurement.
- •Lacking access to the internet via personal computer or mobile device.
- •Unable to read or write in English.
结局指标
主要结局
Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Track changes in fruit and vegetable intake via ASA24 dietary recall food diary.
Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Measure changes in systolic/diastolic blood pressure (mmHg) to assess cardiovascular disease (CVD) risk.
Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
时间窗: Baseline; 6 weeks and 3 months
Measure of renal damage.
次要结局
- Metabolomics will be used to profile how changes in diet effects disease risk.(Baseline and 6 Weeks)