N/A
N=142
Five, Plus Nuts and Beans for Kidneys
Chronic Kidney Disease · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03299816 ↗Enrolled (actual)
142
Serious AEs
9.9%
Results posted
Jun 2023
Primary outcome: Primary: Change in Urinary Albumin Excretion From Baseline to 4 Months — -28.6; -5.6 mg/g — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coaching DASH group (C-DASH) (Behavioral); Self-Shopping DASH group (S-DASH) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2021
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 |
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.
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.