Chronic Kidney DiseasesCPDNCT04117204
Cardiorenal Protective Diet
A study testing Fruits and Vegetables in people with Chronic Kidney Diseases and Cardiovascular Diseases, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension
- What is being tested?
- Fruits and Vegetables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Health and Wellness Center
Dallas, Texas, 75210
About this study
Official title: 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.
- Being tested
- Fruits and Vegetables
- Keywords
- CVD, Dietary Intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruits and VegetablesOther
Fruits and Vegetable delivery, once a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fruits and Vegetables | Experimental | 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. Receives: Other: Fruits and Vegetables |
| Wait List Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 6 weeks and 3 months
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.
Measured: Baseline; 6 weeks and 3 months
Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
Measure of renal damage.
Measured: Baseline; 6 weeks and 3 months
Secondary outcomes (1)
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.
Measured: Baseline and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Jun 2019
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Kitzman, PhD, Principal investigator, Baylor Scott & White Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117204
- Sponsor's protocol ID
- 018-095
- Acronym
- CPD
- Status last verified
- Jan 2021
- First submitted
- 3 Oct 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available.
PubMed 26885959Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
PubMed 26925525Gargiulo R, Suhail F, Lerma EV. Cardiovascular disease and chronic kidney disease. Dis Mon. 2015 Sep;61(9):403-13. doi: 10.1016/j.disamonth.2015.07.005. Epub 2015 Aug 29. No abstract available.
PubMed 26328516Banks J, Marmot M, Oldfield Z, Smith JP. Disease and disadvantage in the United States and in England. JAMA. 2006 May 3;295(17):2037-45. doi: 10.1001/jama.295.17.2037.
PubMed 16670412So BH, Methven S, Hair MD, Jardine AG, MacGregor MS. Socio-economic status influences chronic kidney disease prevalence in primary care: a community-based cross-sectional analysis. Nephrol Dial Transplant. 2015 Jun;30(6):1010-7. doi: 10.1093/ndt/gfu408. Epub 2015 Jan 13.
PubMed 25586406Vart P, Gansevoort RT, Coresh J, Reijneveld SA, Bultmann U. Socioeconomic measures and CKD in the United States and The Netherlands. Clin J Am Soc Nephrol. 2013 Oct;8(10):1685-93. doi: 10.2215/CJN.12521212. Epub 2013 Jun 27.
PubMed 23813554Peralta CA, Vittinghoff E, Bansal N, Jacobs D Jr, Muntner P, Kestenbaum B, Lewis C, Siscovick D, Kramer H, Shlipak M, Bibbins-Domingo K. Trajectories of kidney function decline in young black and white adults with preserved GFR: results from the Coronary Artery Risk Development in Young Adults (CARDIA) study. Am J Kidney Dis. 2013 Aug;62(2):261-6. doi: 10.1053/j.ajkd.2013.01.012. Epub 2013 Mar 7.
PubMed 23473985Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
PubMed 21881553Goraya N, Simoni J, Jo CH, Wesson DE. A comparison of treating metabolic acidosis in CKD stage 4 hypertensive kidney disease with fruits and vegetables or sodium bicarbonate. Clin J Am Soc Nephrol. 2013 Mar;8(3):371-81. doi: 10.2215/CJN.02430312. Epub 2013 Feb 7.
PubMed 23393104Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
PubMed 24694986Young BA, Katz R, Boulware LE, Kestenbaum B, de Boer IH, Wang W, Fulop T, Bansal N, Robinson-Cohen C, Griswold M, Powe NR, Himmelfarb J, Correa A. Risk Factors for Rapid Kidney Function Decline Among African Americans: The Jackson Heart Study (JHS). Am J Kidney Dis. 2016 Aug;68(2):229-239. doi: 10.1053/j.ajkd.2016.02.046. Epub 2016 Apr 9.
PubMed 27066930Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Muller MJ, Oberritter H, Schulze M, Stehle P, Watzl B. Critical review: vegetables and fruit in the prevention of chronic diseases. Eur J Nutr. 2012 Sep;51(6):637-63. doi: 10.1007/s00394-012-0380-y. Epub 2012 Jun 9.
PubMed 22684631Rehm CD, Penalvo JL, Afshin A, Mozaffarian D. Dietary Intake Among US Adults, 1999-2012. JAMA. 2016 Jun 21;315(23):2542-53. doi: 10.1001/jama.2016.7491.
PubMed 27327801Newgard CB. Metabolomics and Metabolic Diseases: Where Do We Stand? Cell Metab. 2017 Jan 10;25(1):43-56. doi: 10.1016/j.cmet.2016.09.018. Epub 2016 Oct 27.
PubMed 28094011Ganna A, Salihovic S, Sundstrom J, Broeckling CD, Hedman AK, Magnusson PK, Pedersen NL, Larsson A, Siegbahn A, Zilmer M, Prenni J, Arnlov J, Lind L, Fall T, Ingelsson E. Large-scale metabolomic profiling identifies novel biomarkers for incident coronary heart disease. PLoS Genet. 2014 Dec 11;10(12):e1004801. doi: 10.1371/journal.pgen.1004801. eCollection 2014 Dec.
PubMed 25502724
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT04117204
- Acronym / sponsor ID
- CPD / 018-095
- Keywords
- CVD, Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruits and Vegetables | Experimental | Other: Fruits and VegetablesThis 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. |
| Wait List Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruits and VegetablesFruits and Vegetable delivery, once a week for 12 weeks. | Other | Fruits and Vegetables |
Primary outcome
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.
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.
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.
1 secondary outcome
Metabolomics will be used to profile how changes in diet effects disease risk.
Time frame: Baseline and 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 26885959Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available.
- Background: PubMed 26925525Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
- Background: PubMed 26328516Gargiulo R, Suhail F, Lerma EV. Cardiovascular disease and chronic kidney disease. Dis Mon. 2015 Sep;61(9):403-13. doi: 10.1016/j.disamonth.2015.07.005. Epub 2015 Aug 29. No abstract available.
- Background: PubMed 16670412Banks J, Marmot M, Oldfield Z, Smith JP. Disease and disadvantage in the United States and in England. JAMA. 2006 May 3;295(17):2037-45. doi: 10.1001/jama.295.17.2037.
- Background: PubMed 25586406So BH, Methven S, Hair MD, Jardine AG, MacGregor MS. Socio-economic status influences chronic kidney disease prevalence in primary care: a community-based cross-sectional analysis. Nephrol Dial Transplant. 2015 Jun;30(6):1010-7. doi: 10.1093/ndt/gfu408. Epub 2015 Jan 13.
- Background: PubMed 23813554Vart P, Gansevoort RT, Coresh J, Reijneveld SA, Bultmann U. Socioeconomic measures and CKD in the United States and The Netherlands. Clin J Am Soc Nephrol. 2013 Oct;8(10):1685-93. doi: 10.2215/CJN.12521212. Epub 2013 Jun 27.
- Background: PubMed 23473985Peralta CA, Vittinghoff E, Bansal N, Jacobs D Jr, Muntner P, Kestenbaum B, Lewis C, Siscovick D, Kramer H, Shlipak M, Bibbins-Domingo K. Trajectories of kidney function decline in young black and white adults with preserved GFR: results from the Coronary Artery Risk Development in Young Adults (CARDIA) study. Am J Kidney Dis. 2013 Aug;62(2):261-6. doi: 10.1053/j.ajkd.2013.01.012. Epub 2013 Mar 7.
- Background: PubMed 21881553Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
- Background: PubMed 23393104Goraya N, Simoni J, Jo CH, Wesson DE. A comparison of treating metabolic acidosis in CKD stage 4 hypertensive kidney disease with fruits and vegetables or sodium bicarbonate. Clin J Am Soc Nephrol. 2013 Mar;8(3):371-81. doi: 10.2215/CJN.02430312. Epub 2013 Feb 7.
- Background: PubMed 24694986Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
- Background: PubMed 27066930Young BA, Katz R, Boulware LE, Kestenbaum B, de Boer IH, Wang W, Fulop T, Bansal N, Robinson-Cohen C, Griswold M, Powe NR, Himmelfarb J, Correa A. Risk Factors for Rapid Kidney Function Decline Among African Americans: The Jackson Heart Study (JHS). Am J Kidney Dis. 2016 Aug;68(2):229-239. doi: 10.1053/j.ajkd.2016.02.046. Epub 2016 Apr 9.
- Background: PubMed 22684631Boeing H, Bechthold A, Bub A, Ellinger S, Haller D, Kroke A, Leschik-Bonnet E, Muller MJ, Oberritter H, Schulze M, Stehle P, Watzl B. Critical review: vegetables and fruit in the prevention of chronic diseases. Eur J Nutr. 2012 Sep;51(6):637-63. doi: 10.1007/s00394-012-0380-y. Epub 2012 Jun 9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Kitzman, PhD principal investigator
Baylor Scott & White Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruits and Vegetables in people with Chronic Kidney Diseases and Cardiovascular Diseases, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months. (time frame: Baseline; 6 weeks and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117204, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.