Clinical trial NCT04117204: Cardiorenal Protective Diet
Official title: Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Cardiovascular Diseases
Hypertension
Keywords: CVD
Dietary Intervention
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
timeFrame: Baseline; 6 weeks and 3 months
measure: Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months.
timeFrame: Baseline; 6 weeks and 3 months
measure: Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
timeFrame: Baseline; 6 weeks and 3 months
Secondary outcomes:
measure: Metabolomics will be used to profile how changes in diet effects disease risk.
timeFrame: Baseline and 6 Weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Health and Wellness Center
state: Texas
Study officials:
affiliation: Baylor Scott & White Health and Wellness Center
name: Heather Kitzman, PhD
role: PRINCIPAL_INVESTIGATOR
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