N/A
Completed N=142
Five, Plus Nuts and Beans for Kidneys
Source: ClinicalTrials.gov NCT03299816 ↗Enrolled (actual)
142
Serious AEs
9.9%
Results posted
Jun 2023
Primary outcomePrimary: Change in Urinary Albumin Excretion From Baseline to 4 Months — -28.6; -5.6 mg/g — p=0.17
Summary
This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Albumin Excretion From Baseline to 4 Months |
-28.6; -5.6 | 0.17 |
| SECONDARY Change in Systolic Blood Pressure From Baseline to 4 Months |
-1.4; 0.9 | 0.36 |
| SECONDARY Change in Systolic Blood Pressure From Baseline to 12 Months |
1.5; -1.6 | 0.33 |
| SECONDARY Change in Urinary Albumin Excretion From Baseline to 12 Months |
-11.5; -1.4 | 0.61 |
Eligibility Criteria
Inclusion Criteria
- Self-identified African American race
- Age 21 years or older
- Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2.
- Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).
- Must have a systolic blood pressure of 9%).
- Patients with a serum potassium >4.6 milliequivalent (mEq) /L45
- Urine ACR ≥ 1,000 mg/g
Data sourced from ClinicalTrials.gov (NCT03299816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.