High Blood PressureFivePlusNCT01689844
Randomized Trial of Tailored Dietary Advice to Lower Blood Pressure
A study testing DASH Plus and DASH - C in people with High Blood Pressure, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- DASH Plus and DASH - C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Community Physicians, East Baltimore Medical Center
Baltimore, Maryland, 21202
About this study
Official title: Five Plus Nuts and Beans Trial
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.
Read the detailed description
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.
- Conditions
- High Blood Pressure
- Being tested
- DASH Plus, DASH - C
- Keywords
- controlled high blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH PlusBehavioural
DASH diet advice and guided shopping for high postassium foods at a local supermarket
DASH - CBehavioural
Brief DASH dietary advice, No shopping guidance at the local supermarket.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral, DASH Plus - Dietary advice | Active comparator | This group will receive DASH diet advice and guided ordering of fruits, vegetables, nuts and beans that are high in potassium from a local supermarket. Receives: Behavioral: DASH Plus |
| DASH - C | Other | DASH C Group will receive brief DASH diet advice and will be able to make non- guided purchases of food products from the local supermarket. Receives: Behavioral: DASH - C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Daytime systolic blood pressure determined by OMRON 907-xl blood pressure monitoring, will be the primary outcome measurement
Measured: 8-wks follow-up
Secondary outcomes (1)
Fasting glucose, lipids and uric acid; urine K and Na excretion
Fasting blood collections will occur in the morning after an overnight fast.
Measured: 8-wks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Edgar R. Miller, III, Johns Hopkins University
- Investigators
- Edgar R Miller III, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689844
- Sponsor's protocol ID
- NA00051935
- Other IDs
- P50CA148087-01
- Acronym
- FivePlus
- Status last verified
- Aug 2016
- First submitted
- 27 Apr 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Juraschek SP, White K, Tang O, Yeh HC, Cooper LA, Miller ER 3rd. Effects of a Dietary Approach to Stop Hypertension (DASH) Diet Intervention on Serum Uric Acid in African Americans With Hypertension. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1509-1516. doi: 10.1002/acr.23515. Epub 2018 Aug 21.
PubMed 29342506
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Plus Nuts and Beans Trial
- ClinicalTrials.gov ID
- NCT01689844
- Acronym / sponsor ID
- FivePlus / NA00051935
- Conditions
- High Blood Pressure
- Keywords
- controlled high blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral, DASH Plus - Dietary advice | Active comparator | Behavioral: DASH PlusThis group will receive DASH diet advice and guided ordering of fruits, vegetables, nuts and beans that are high in potassium from a local supermarket. |
| DASH - C | Other | Behavioral: DASH - CDASH C Group will receive brief DASH diet advice and will be able to make non- guided purchases of food products from the local supermarket. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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%),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH PlusDASH diet advice and guided shopping for high postassium foods at a local supermarket | Behavioural | Behavioral, DASH Plus - Dietary advice |
| DASH - CBrief DASH dietary advice, No shopping guidance at the local supermarket. | Behavioural | DASH - C |
Primary outcome
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
1 secondary outcome
Fasting glucose, lipids and uric acid; urine K and Na excretion
Time frame: 8-wks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 29342506Juraschek SP, White K, Tang O, Yeh HC, Cooper LA, Miller ER 3rd. Effects of a Dietary Approach to Stop Hypertension (DASH) Diet Intervention on Serum Uric Acid in African Americans With Hypertension. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1509-1516. doi: 10.1002/acr.23515. Epub 2018 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar R Miller III, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Plus and DASH - C in people with High Blood Pressure, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 8-wks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.