Cardiorenal Protective Diet

Study Overview
=================
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.

Official Title
-----------------
Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.

Conditions
-----------------
Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension

Intervention / Treatment
-----------------
* Other: Fruits and Vegetables


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruits and Vegetables<br>This group will receive a prescribed amount of free fruits and vegetables (F&V) for 6 weeks of pick-up at a farm stand or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 6 weeks with minimal contact. | Other: Fruits and Vegetables<br>* Fruits and Vegetable delivery, once a week for 12 weeks.<br>|
| No Intervention: Wait List Control<br>This group will not receive a prescribed amount of free fruits and vegetables (F&V) for 12 weeks. They will serve as the control group. After 12 weeks of control and data comparisons, they will be given 12 weeks of vouchers with minimal contact. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months. | Track changes in fruit and vegetable intake via ASA24 dietary recall food diary. | Baseline; 6 weeks and 3 months | 
| Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months. | Measure changes in systolic/diastolic blood pressure (mmHg) to assess cardiovascular disease (CVD) risk. | Baseline; 6 weeks and 3 months | 
| Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months. | Measure of renal damage. | Baseline; 6 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics will be used to profile how changes in diet effects disease risk. | Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types. | Baseline and 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CVD, Dietary Intervention