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CPD: Cardiorenal Protective Diet

Sponsor
Baylor Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04117204
Collaborator
(none)
101
Enrollment
1
Location
2
Arms
17.2
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fruits and Vegetables
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Nov 6, 2020
Actual Study Completion Date :
Nov 6, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baylor Scott & White Health and Wellness Center Dallas Texas United States 75210

Sponsors and Collaborators

  • Baylor Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT04117204
Other Study ID Numbers:
  • 018-095
First Posted:
Oct 7, 2019
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Baylor Research Institute
CVD
Dietary Intervention
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases

Study Results

No Results Posted as of Jan 29, 2021