Cardiorenal Protective Diet

Hypertension Clinical Trial

— CPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117204
• Other study ID #: 018-095
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: November 6, 2020

Study information

• Verified date: January 2021
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Fruits and Vegetables
Fruits and Vegetable delivery, once a week for 12 weeks.

Locations

Country	Name	City	State
United States	Baylor Scott & White Health and Wellness Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.	Track changes in fruit and vegetable intake via ASA24 dietary recall food diary.	Baseline; 6 weeks and 3 months
Primary	Changes from baseline in systolic and diastolic blood pressure at 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
Primary	Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.	Measure of renal damage.	Baseline; 6 weeks and 3 months
Secondary	Metabolomics will be used to profile how changes in diet effects disease risk.	Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types.	Baseline and 6 Weeks