Cardiorenal Protective Diet

Baylor Research Institute101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

101

Conditions

Chronic Kidney Diseases Cardiovascular Diseases Hypertension

Interventions

Fruits and VegetablesOTHER

Fruits and Vegetable delivery, once a week for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Baylor Scott & White Health and Wellness Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline; 6 weeks and 3 months

Secondary Outcomes

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.

Time frame: Baseline and 6 Weeks

Data from ClinicalTrials.gov

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