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Completed

NCT Number: NCT01689844

Randomized Trial of Tailored Dietary Advice to Lower Blood Pressure

The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into practice for 120 African American participants who are on stable doses of antihypertensive medications. The first arm of our study offers minimal DASH-oriented dietary advice along with a food credit at a local supermarket where they make their own decision of what to eat. The second arm consists of a single one-hour session with a nutrition expert who provides choices and places an on-line order from a community grocery store (Santoni's Market) with targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine potassium excretion, and self-report consumption of fruits and vegetables during the same period.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Physicians, East Baltimore Medical Center

Baltimore, Maryland, 21202, United States

About this study

Unhealthy diets have many social determinants; however, there is a markedly lower availability of components of the DASH diet-recommended foods (such as fresh fruits and vegetables, skim milk and whole grain foods) in predominantly African-American and lower-income neighborhoods compared with Caucasian and higher-income neighborhoods. Unhealthy dietary consumption patterns contribute, in part, to hypertension through deficiencies in potassium, magnesium and vitamin C - all micronutrients with independent blood pressure-lowering effects. Furthermore, use of thiazide-based antihypertensive therapy often worsens deficiencies through increased urinary excretion. Strategies that take into account the multi-level nature of the problem of poor nutrition among low income African Americans are needed to improve adherence to dietary recommendations and reverse micronutrient deficiencies in hypertensive adults. The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into practice for 120 African American participants who are on stable doses of antihypertensive medications. The first arm of our study offers minimal DASH-oriented dietary advice along with a food credit at a local supermarket where they make their own decision of what to eat. The second arm consists of a single one-hour session with a nutrition expert who provides choices and places an on-line order from a community grocery store (Santoni's Market) with targeted purchases of fruits, vegetables, nuts and beans. Following the initial contact, there is a weekly call with the coordinator for a $30 per week food delivery. Food orders are delivered for pick-up weekly by participants at a Baltimore Public Library in participant's neighborhood. Our primary outcome is change in blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine potassium excretion, and self-report consumption of fruits and vegetables during the same period. After completion of the active phase of the trial, we will follow blood pressures in the electronic medical record for one year to assess long-term effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must be age 21 or older,
  • have a diagnosis of hypertension or pre-hypertension
  • under regular care with their physician, and
  • compliant with medications.
  • systolic blood pressure of 120-140 mmHg and/or
  • a diastolic blood pressure of 80-90 mmHg (average of two visits)
  • on stable doses of antihypertensive medications for a minimum of two months prior to randomization, (and for the duration of the study).
  • be able to follow all trial procedures.

Exclusion criteria

  • cardiovascular event within 6 months,
  • chronic disease that might interfere with trial participation (e.g. chronic kidney disease (estimated GFR < 60 cc/min),
  • unwillingness or inability to adopt a DASH-like diet, and
  • consumption of more than 14 alcoholic drinks per week,
  • poorly controlled diabetes (Hemoglobin A1c >9%),
  • use of insulin,
  • use of mineral supplements or an unwillingness to stop supplements one month prior to randomization and refrain from the supplements during the study.

Treatment and study plan

DASH Plus

Behavioral

DASH diet advice and guided shopping for high postassium foods at a local supermarket

DASH - C

Behavioral

Brief DASH dietary advice, No shopping guidance at the local supermarket.

Primary outcomes

  1. Blood Pressure

    Time frame: 8-wks follow-up

    Daytime systolic blood pressure determined by OMRON 907-xl blood pressure monitoring, will be the primary outcome measurement

Secondary outcomes

  1. Fasting glucose, lipids and uric acid; urine K and Na excretion

    Time frame: 8-wks follow-up

    Fasting blood collections will occur in the morning after an overnight fast.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Five Plus Nuts and Beans Trial

Acronym: FivePlus

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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