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OpenTrials
Completed

NCT Number: NCT04117204

Cardiorenal Protective Diet

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.

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Key information

Conditions

Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White Health and Wellness Center

Dallas, Texas, 75210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fruits and Vegetables

Other

Fruits and Vegetable delivery, once a week for 12 weeks.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: CPD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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