Clinical trial NCT03299816: Five, Plus Nuts and Beans for Kidneys
Official title: Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hypertension
Keywords: Chronic Kidney Disease
Hypertension
Albuminuria
African Americans
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-10-03
Enrollment: 142
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized controlled trial with two parallel arms.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.

150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.

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 \<=160 mmHg and a diastolic blood pressure of \<=100 mmHg (average of two visits)
* Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.

Exclusion Criteria:

* Cardiovascular (CV) event within 6 months
* Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2)
* Unwillingness or inability to adopt a DASH-like diet
* Consumes over 14 alcoholic drinks per week
* Poorly controlled diabetes (Hemoglobin A1c \>9%).
* Patients with a serum potassium \>4.6 milliequivalent (mEq) /L45
* Urine ACR ≥ 1,000 mg/g

Primary outcomes:
measure: Change in Urinary Albumin Excretion From Baseline to 4 Months
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure From Baseline to 4 Months
timeFrame: Baseline,4 months
measure: Change in Systolic Blood Pressure From Baseline to 12 Months
timeFrame: Baseline, end of study (approximately 12 months)
measure: Change in Urinary Albumin Excretion From Baseline to 12 Months
timeFrame: Baseline, end of study (approximately 12 months)
Other outcomes:
measure: Change in Urinary Albumin Excretion From Baseline to 1 Month
timeFrame: Baseline, 1 month
measure: Change in Systolic Blood Pressure From Baseline to 1 Month
timeFrame: Baseline, 1 month
Locations:
city: Baltimore
country: United States
facility: East Baltimore Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Deidra Crews, MD, ScM
role: PRINCIPAL_INVESTIGATOR
References: