Cardiorenal Protective Diet

Not Applicable

Completed

• Conditions: Hypertension; Chronic Kidney Diseases; Cardiovascular Diseases
• Interventions: Other: Fruits and Vegetables

• Registration Number: NCT04117204
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fruits and Vegetables	Fruits and Vegetables	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baylor Scott & White Health and Wellness Center; 🇺🇸 Dallas, Texas, United States