Cardiorenal Protective Diet (CPD)

January 28, 2021 updated by: Baylor Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75210
        • Baylor Scott & White Health and Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Fruits and Vegetables
Fruits and Vegetable delivery, once a week for 12 weeks.
No Intervention: Wait List Control
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.
Time Frame: Baseline; 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.
Time Frame: Baseline; 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.
Time Frame: Baseline; 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.
Time Frame: Baseline and 6 Weeks
Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types.
Baseline and 6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Heather Kitzman, PhD, Baylor Scott & White Health and Wellness Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

November 6, 2020

Study Completion (Actual)

November 6, 2020

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018-095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Fruits and Vegetables

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe