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Cardiorenal Protective Diet (CPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117204
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Cardiovascular Diseases Hypertension Other: Fruits and Vegetables Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : June 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117204


Contacts
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Contact: Heather Kitzman, PhD 214-865-3082 Heather.KitzmanCarmichael@BSWHealth.org
Contact: Brian Vilayvanh, BSN, RN 214-865-3071 Brian.Vilayvanh@BSWHealth.org

Locations
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United States, Texas
Baylor Scott & White Health and Wellness Center Recruiting
Dallas, Texas, United States, 75210
Contact: Brian Vilayvanh, BSN, RN    214-865-3071    Brian.Vilayvanh@BSWHealth.org   
Contact: Patricia Allison, CHW    214-865-3053    Patricia.Allison@BSWHealth.org   
Principal Investigator: Heather Kitzman, PhD         
Sub-Investigator: Donald Wesson, MD, MBA         
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Heather Kitzman, PhD Baylor Scott & White Health and Wellness Center
Publications:
Dallmann G, Klavins K, Koal T. Targeted Quantitative Metabolomics Using Dried Plasma Spot Cards. https:novilytic.com/wp-content/uploads/2015/01/Metabolomics-with-Noviplex-Cards.pdf
Institute Nc. ASA24 Automated Self-Administered 24-Hour Dietary Assessment Tool. http://epi.grants.cancer.gov/asa24/
Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic Evaluation in Clinical Trials. Oxford: Oxford University Press; 2007.

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT04117204    
Other Study ID Numbers: 018-095
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency