Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension
Conditions
Keywords
CVD, Dietary Intervention
Brief summary
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.
Interventions
Fruits and Vegetable delivery, once a week for 12 weeks.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months. | 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. | 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. | Baseline; 6 weeks and 3 months | Measure of renal damage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolomics will be used to profile how changes in diet effects disease risk. | Baseline and 6 Weeks | Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types. |
Countries
United States
Outcome results
None listed