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Cardiorenal Protective Diet (CPD)

Primary Purpose

Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruits and Vegetables
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring CVD, Dietary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Baylor Scott & White Health and Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fruits and Vegetables

Wait List Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
Measure of renal damage.

Secondary Outcome Measures

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.

Full Information

First Posted
October 3, 2019
Last Updated
January 28, 2021
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04117204
Brief Title
Cardiorenal Protective Diet
Acronym
CPD
Official Title
Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension
Keywords
CVD, Dietary Intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fruits and Vegetables
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fruits and Vegetables
Intervention Description
Fruits and Vegetable delivery, once a week for 12 weeks.
Primary Outcome Measure Information:
Title
Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months.
Description
Track changes in fruit and vegetable intake via ASA24 dietary recall food diary.
Time Frame
Baseline; 6 weeks and 3 months
Title
Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months.
Description
Measure changes in systolic/diastolic blood pressure (mmHg) to assess cardiovascular disease (CVD) risk.
Time Frame
Baseline; 6 weeks and 3 months
Title
Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months.
Description
Measure of renal damage.
Time Frame
Baseline; 6 weeks and 3 months
Secondary Outcome Measure Information:
Title
Metabolomics will be used to profile how changes in diet effects disease risk.
Description
Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types.
Time Frame
Baseline and 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Kitzman, PhD
Organizational Affiliation
Baylor Scott & White Health and Wellness Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Scott & White Health and Wellness Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26885959
Citation
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.
Results Reference
background
PubMed Identifier
26925525
Citation
Saran 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.
Results Reference
background
PubMed Identifier
26328516
Citation
Gargiulo 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.
Results Reference
background
PubMed Identifier
16670412
Citation
Banks 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.
Results Reference
background
PubMed Identifier
25586406
Citation
So 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.
Results Reference
background
PubMed Identifier
23813554
Citation
Vart 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.
Results Reference
background
PubMed Identifier
23473985
Citation
Peralta 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.
Results Reference
background
PubMed Identifier
21881553
Citation
Goraya 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.
Results Reference
background
PubMed Identifier
23393104
Citation
Goraya 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.
Results Reference
background
PubMed Identifier
24694986
Citation
Goraya 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.
Results Reference
background
PubMed Identifier
27066930
Citation
Young 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.
Results Reference
background
PubMed Identifier
22684631
Citation
Boeing 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.
Results Reference
background
PubMed Identifier
27327801
Citation
Rehm 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.
Results Reference
background
PubMed Identifier
28094011
Citation
Newgard 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.
Results Reference
background
PubMed Identifier
25502724
Citation
Ganna 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.
Results Reference
background
PubMed Identifier
28028134
Citation
Leaf DE, Jacob KA, Srivastava A, Chen ME, Christov M, Juppner H, Sabbisetti VS, Martin A, Wolf M, Waikar SS. Fibroblast Growth Factor 23 Levels Associate with AKI and Death in Critical Illness. J Am Soc Nephrol. 2017 Jun;28(6):1877-1885. doi: 10.1681/ASN.2016080836. Epub 2016 Dec 27.
Results Reference
background
PubMed Identifier
28006765
Citation
Xue C, Yang B, Zhou C, Dai B, Liu Y, Mao Z, Yu S, Mei C. Fibroblast Growth Factor 23 Predicts All-Cause Mortality in a Dose-Response Fashion in Pre-Dialysis Patients with Chronic Kidney Disease. Am J Nephrol. 2017;45(2):149-159. doi: 10.1159/000454959. Epub 2016 Dec 23.
Results Reference
background
PubMed Identifier
28075340
Citation
Rescigno T, Micolucci L, Tecce MF, Capasso A. Bioactive Nutrients and Nutrigenomics in Age-Related Diseases. Molecules. 2017 Jan 8;22(1):105. doi: 10.3390/molecules22010105.
Results Reference
background
PubMed Identifier
25835731
Citation
Wilson DK, Kitzman-Ulrich H, Resnicow K, Van Horn ML, St George SM, Siceloff ER, Alia KA, McDaniel T, Heatley V, Huffman L, Coulon S, Prinz R. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families. Contemp Clin Trials. 2015 May;42:145-57. doi: 10.1016/j.cct.2015.03.009. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
17716952
Citation
Wilson DK, Kitzman-Ulrich H, Williams JE, Saunders R, Griffin S, Pate R, Van Horn ML, Evans A, Hutto B, Addy CL, Mixon G, Sisson SB. An overview of "The Active by Choice Today" (ACT) trial for increasing physical activity. Contemp Clin Trials. 2008 Jan;29(1):21-31. doi: 10.1016/j.cct.2007.07.001. Epub 2007 Jul 17.
Results Reference
background
PubMed Identifier
20801233
Citation
Wilson DK, Trumpeter NN, St George SM, Coulon SM, Griffin S, Lee Van Horn M, Lawman HG, Wandersman A, Egan B, Forthofer M, Goodlett BD, Kitzman-Ulrich H, Gadson B. An overview of the "Positive Action for Today's Health" (PATH) trial for increasing walking in low income, ethnic minority communities. Contemp Clin Trials. 2010 Nov;31(6):624-33. doi: 10.1016/j.cct.2010.08.009. Epub 2010 Aug 27.
Results Reference
background
PubMed Identifier
28807739
Citation
Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.
Results Reference
background
PubMed Identifier
25369633
Citation
Armstrong C; Joint National Committee. JNC8 guidelines for the management of hypertension in adults. Am Fam Physician. 2014 Oct 1;90(7):503-4. No abstract available.
Results Reference
background
PubMed Identifier
26287973
Citation
Scialla JJ, Parekh RS, Eustace JA, Astor BC, Plantinga L, Jaar BG, Shafi T, Coresh J, Powe NR, Melamed ML. Race, Mineral Homeostasis and Mortality in Patients with End-Stage Renal Disease on Dialysis. Am J Nephrol. 2015;42(1):25-34. doi: 10.1159/000438999. Epub 2015 Aug 20.
Results Reference
background
PubMed Identifier
24119845
Citation
Gutierrez OM, Rostand SG. Chronic kidney disease in African Americans: past, present, and future: introduction. Semin Nephrol. 2013 Sep;33(5):407-8. doi: 10.1016/j.semnephrol.2013.07.001. No abstract available.
Results Reference
background
PubMed Identifier
26912553
Citation
Gutierrez OM, Parsa A, Isakova T, Scialla JJ, Chen J, Flack JM, Nessel LC, Gupta J, Bellovich KA, Steigerwalt S, Sondheimer JH, Wright JT Jr, Feldman HI, Kusek JW, Lash JP, Wolf M. Genetic African Ancestry and Markers of Mineral Metabolism in CKD. Clin J Am Soc Nephrol. 2016 Apr 7;11(4):653-62. doi: 10.2215/CJN.08020715. Epub 2016 Feb 8.
Results Reference
background
PubMed Identifier
26152403
Citation
Gutierrez OM, Judd SE, Irvin MR, Zhi D, Limdi N, Palmer ND, Rich SS, Sale MM, Freedman BI. APOL1 nephropathy risk variants are associated with altered high-density lipoprotein profiles in African Americans. Nephrol Dial Transplant. 2016 Apr;31(4):602-8. doi: 10.1093/ndt/gfv229. Epub 2015 Jul 6.
Results Reference
background
PubMed Identifier
25149893
Citation
Saneei P, Salehi-Abargouei A, Esmaillzadeh A, Azadbakht L. Influence of Dietary Approaches to Stop Hypertension (DASH) diet on blood pressure: a systematic review and meta-analysis on randomized controlled trials. Nutr Metab Cardiovasc Dis. 2014 Dec;24(12):1253-61. doi: 10.1016/j.numecd.2014.06.008. Epub 2014 Jun 27.
Results Reference
background
PubMed Identifier
24586991
Citation
Breier M, Wahl S, Prehn C, Fugmann M, Ferrari U, Weise M, Banning F, Seissler J, Grallert H, Adamski J, Lechner A. Targeted metabolomics identifies reliable and stable metabolites in human serum and plasma samples. PLoS One. 2014 Feb 24;9(2):e89728. doi: 10.1371/journal.pone.0089728. eCollection 2014.
Results Reference
background
PubMed Identifier
26274920
Citation
Carayol M, Licaj I, Achaintre D, Sacerdote C, Vineis P, Key TJ, Onland Moret NC, Scalbert A, Rinaldi S, Ferrari P. Reliability of Serum Metabolites over a Two-Year Period: A Targeted Metabolomic Approach in Fasting and Non-Fasting Samples from EPIC. PLoS One. 2015 Aug 14;10(8):e0135437. doi: 10.1371/journal.pone.0135437. eCollection 2015.
Results Reference
background
PubMed Identifier
24817014
Citation
Nkuipou-Kenfack E, Duranton F, Gayrard N, Argiles A, Lundin U, Weinberger KM, Dakna M, Delles C, Mullen W, Husi H, Klein J, Koeck T, Zurbig P, Mischak H. Assessment of metabolomic and proteomic biomarkers in detection and prognosis of progression of renal function in chronic kidney disease. PLoS One. 2014 May 9;9(5):e96955. doi: 10.1371/journal.pone.0096955. eCollection 2014.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
27160690
Citation
Hong DS, Oh IH, Park JS, Lee CH, Kang CM, Kim GH. Evaluation of Urinary Indices for Albuminuria and Proteinuria in Patients with Chronic Kidney Disease. Kidney Blood Press Res. 2016;41(3):258-66. doi: 10.1159/000443429. Epub 2016 Apr 29.
Results Reference
background
PubMed Identifier
25964261
Citation
Thompson FE, Dixit-Joshi S, Potischman N, Dodd KW, Kirkpatrick SI, Kushi LH, Alexander GL, Coleman LA, Zimmerman TP, Sundaram ME, Clancy HA, Groesbeck M, Douglass D, George SM, Schap TE, Subar AF. Comparison of Interviewer-Administered and Automated Self-Administered 24-Hour Dietary Recalls in 3 Diverse Integrated Health Systems. Am J Epidemiol. 2015 Jun 15;181(12):970-8. doi: 10.1093/aje/kwu467. Epub 2015 May 10.
Results Reference
background
Citation
Institute Nc. ASA24 Automated Self-Administered 24-Hour Dietary Assessment Tool. http://epi.grants.cancer.gov/asa24/
Results Reference
background
Citation
Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic Evaluation in Clinical Trials. Oxford: Oxford University Press; 2007.
Results Reference
background
PubMed Identifier
8827972
Citation
Russell LB, Gold MR, Siegel JE, Daniels N, Weinstein MC. The role of cost-effectiveness analysis in health and medicine. Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996 Oct 9;276(14):1172-7.
Results Reference
background

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Cardiorenal Protective Diet

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