PrehypertensionNCT04142138
When the Kidney Reacts to Nutritional Changes
A study testing DASH in people with Prehypertension, run by Rockefeller University at 1 site in United States.
Trial summary
Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prehypertension
- What is being tested?
- DASH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2020to 30 Apr 2021
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- any gender, 18-60 years of age
- self described as White or Black individuals
- prehypertensives (=stage 1 hypertension) defined as sustolic blood pressure of 130-159 mmHG and/or diastolic blood pressure between 80-100.
- adequate dentition to consume fruits and vegetables as described for DASH -
Who cannot join
- Preexisting kidney disease structural or parenchymal including APCKD (adult polycystic kidney disease), single kidney (as assessed by ultrasound including size differences >3 cm in diameter between kidneys), or evidence of RAS (renal artery stenosis)
- Pregnant
- HIV
- taking medications for diabetes, hyperlipidemia, cardiac disease, Medications for birth control, psychiatirc conditions, and sleep are Ok. Vitamins and herbs are Ok if continued throughout the study. Thyroid meds are acceptable if the TSH is within normal limits.
- Diabetes as defined by hemoglobin A1c > 6.5% and/or fasting glucose > 125 mg/dl
- Hyperlipidemia as defined by triglycerides >200 and/or LDL > 150
Show all 16Show fewer
- Hematuria on screening
- RAAS (Renin-Angiotensin-Aldosterone) axis deviation - Aldosterone and Renin should be within normal ranges upon screening.
- BUN > 40mg/dL corrected to body surface area
- Creatinine > 1.3 mg/dL corrected to body surface area
- BMI > 29.9 or < 19
- Current smoker
- Currently, a vegetarian (who does not consume fish and dairy) or a vegan
- Based on medical history, any evidence of an autoimmune disease
- Use of any of the following - ACEi, ARB, spironolactone, diuretics of any class, beta blockers, alpha blockers, nsaids, within the past two weeks
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: Translational Characterization of Blood Pressure Changes Following the Dietary Approach to Stop Hypertension (DASH) Diet- From Nutrition Through Electrolytes to Exosomes.
Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary Approach to Stop Hypertension) diet is a proven effective intervention in lowering blood pressure in multiple populations. In this proof of concept study, volunteers with untreated stage 1 hypertension, defined as mild high blood pressure with numbers in the range of 130 - 139 over 80 - 89, will receive a DASH-based menu during 5 days of hospitalization, during a weekend at home where they will continue the menu, another 5 days as inpatients, followed by a weekend at home on the same menu, and the return to the inpatient unit for an additional day for final testing. Throughout the intervention period, participants will be followed clinically and undergo repeated laboratory testing. The aim of this project is to characterize changes in urine electrolytes and exosome protein abundance pattern during nutritional changes, shifting from a "westernized diet" to a DASH diet.
Read the detailed description
Diet is a major disease modifier of hypertension. The Dietary Approaches to Stop Hypertension diet (DASH) is endorsed nationally and abroad to treat hypertension (HTN) in adults. In the original DASH study, the effect of the combination diet consisting of low salt, high potassium, and low-fat dairy products, was more pronounced in hypertensives and minorities. The magnitude of the effect on blood pressure (BP) of the combination diet was similar to that observed with single drug antihypertensive therapy.
Americans typically consume 3400 mg sodium daily, due to high intakes of processed foods, frequent eating outside the home, and consumption of packaged meals and salty snack foods. Foods consumed outside of the home provide 34% of the sodium intake of Americans.
It is not known exactly how the DASH diet effects its lowering of blood pressure. One of the proposed mechanism of the effect of the DASH diet relies on two components - sodium reduction and potassium supplementation.
In response to potassium supplementation such as in DASH diet, we would expect less sodium to be reabsorbed.
Over the years, adherence to DASH diet has been evaluated using questionnaires. Methods for monitoring sodium intake remain inadequate and flawed. Dietary recall is not reliable, and many patients truly do not realize, and consequently under report, the amount of sodium they consume. The most widely employed method of assessing dietary adherence, the 24-h urine collection to measure sodium excretion, is cumbersome and inconvenient. Evaluating urine sodium to creatinine ratio was validated as a surrogate measure to 24-hour urine collection .
Exosomes: most of the data regarding tissue activity of different channels in response to stimuli, comes from animal studies. Translation of the murine experimental findings to a human setting is difficult and has mostly been inferred using plasma and urinary electrolyte levels as a proxy for renal tubular transporter activity. Transporter proteins from all tubular segments are excreted into the urine in extracellular vesicles. These vesicles therefore provide a non-invasive liquid biopsy access to tubular epithelial cells that could potentially inform on physiological regulation of transporter activity in human kidneys . The proteins that are present in urine are a major area of investigation for proteomics researchers. In normal urine, typically half of the proteins are soluble proteins (49%), and the remaining 48% are sediment precipitated with low-speed centrifugation, and exosomes (3%). All exosomes contain a few common protein components. The cytosolic proteins present on exosomes include annexins, adhesion molecules, proteins that participate in vesicle formation and trafficking and metabolic enzymes. Analysis of urine exosomes can enhance the detectability of relatively low-abundant proteins that have potential pathophysiological significance, and so have become one of the newer trends in the field of urine-biomarker discovery .
Volunteers with hypertension stage 1, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization blood and urine samples will be collected daily, as well as clinical parameters such as blood pressure.
- Conditions
- Prehypertension
- Being tested
- DASH
- Keywords
- inpatient, nutrition
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASHOther
DASH diet is based on low salt, high potassium components, and is comprised of mainly fruits and vegetables. During hospitalization we will collect laboratory data of blood and urine, and follow participants clinically by measuring blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| nutrition implementation | Experimental | Volunteers with prehypertension, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization we will: 1) collect samples of blood and urine daily 2) monitor blood pressure, weight and pulse twice daily 3) collect 24-hour urine, twice during the period of two weeks 4) serve participants a menu based on DASH principles, namely low in sodium and high in potassium. Receives: Other: DASH |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine exosome protein abundance pattern
Mass spectrometry generates a list of proteins for each sample. We will compare fold of change before (Day 1) and after intervention (Day 12) - a true change is defined as 1.5 fold.
Measured: Day 1 and Day 12
urine electrolyte ratio in a spot urine as a surrogate to 24-h urine collection to assess nutritional consumption.
spot urine will be analyzed for sodium and potassium parallel to 24-h urine collection. We will assess the concordance between the 24-h collection and the spot urine ratio of electrolytes. The result will be presented as a ratio of SPOT ratio (sodium/potassium) to 24-h collection ratio (sodium/potassium), for each participant. We will assess how close the ratio of ratios is to one.
Measured: day 1,2,3,4,5,6,8,9,10,11,12,14
24-h urine collection as a measure of adherence to the DASH diet
Urine will be collected throughout 24 hours to analyze electrolyte content, during intervention - twice, at the beginning (day 1) and end of intervention (day 12). We will be measuring daily sodium excretion, the threshold for compliance will be equal to or less than 100MEQ/d. For potassium daily excretion the threshold will be greater than or equal to 90meq/d . The change will be reported as number of participants that have met the defined threshold for compliance.
Measured: day 1, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start22 Feb 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study assesses how nutritional changes, namely DASH diet, change the composition of ion channels in the renal tubule, as exemplified by urine electrolyte ratio.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Bielopolski, MD PhD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142138
- Sponsor's protocol ID
- DBI-1000
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Characterization of Blood Pressure Changes Following the Dietary Approach to Stop Hypertension (DASH) Diet- From Nutrition Through Electrolytes to Exosomes.
- ClinicalTrials.gov ID
- NCT04142138
- Acronym / sponsor ID
- DBI-1000
- Conditions
- Prehypertension
- Keywords
- inpatient, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- 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.
Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary Approach to Stop Hypertension) diet is a proven effective intervention in lowering blood pressure in multiple populations. In this proof of concept study, volunteers with untreated stage 1 hypertension, defined as mild high blood pressure with numbers in the range of 130 - 139 over 80 - 89, will receive a DASH-based menu during 5 days of hospitalization, during a weekend at home where they will continue the menu, another 5 days as inpatients, followed by a weekend at home on the same menu, and the return to the inpatient unit for an additional day for final testing. Throughout the intervention period, participants will be followed clinically and undergo repeated laboratory testing. The aim of this project is to characterize changes in urine electrolytes and exosome protein abundance pattern during nutritional changes, shifting from a "westernized diet" to a DASH diet.
Detailed description
Diet is a major disease modifier of hypertension. The Dietary Approaches to Stop Hypertension diet (DASH) is endorsed nationally and abroad to treat hypertension (HTN) in adults. In the original DASH study, the effect of the combination diet consisting of low salt, high potassium, and low-fat dairy products, was more pronounced in hypertensives and minorities. The magnitude of the effect on blood pressure (BP) of the combination diet was similar to that observed with single drug antihypertensive therapy.
Americans typically consume 3400 mg sodium daily, due to high intakes of processed foods, frequent eating outside the home, and consumption of packaged meals and salty snack foods. Foods consumed outside of the home provide 34% of the sodium intake of Americans.
It is not known exactly how the DASH diet effects its lowering of blood pressure. One of the proposed mechanism of the effect of the DASH diet relies on two components - sodium reduction and potassium supplementation.
In response to potassium supplementation such as in DASH diet, we would expect less sodium to be reabsorbed.
Over the years, adherence to DASH diet has been evaluated using questionnaires. Methods for monitoring sodium intake remain inadequate and flawed. Dietary recall is not reliable, and many patients truly do not realize, and consequently under report, the amount of sodium they consume. The most widely employed method of assessing dietary adherence, the 24-h urine collection to measure sodium excretion, is cumbersome and inconvenient. Evaluating urine sodium to creatinine ratio was validated as a surrogate measure to 24-hour urine collection .
Exosomes: most of the data regarding tissue activity of different channels in response to stimuli, comes from animal studies. Translation of the murine experimental findings to a human setting is difficult and has mostly been inferred using plasma and urinary electrolyte levels as a proxy for renal tubular transporter activity. Transporter proteins from all tubular segments are excreted into the urine in extracellular vesicles. These vesicles therefore provide a non-invasive liquid biopsy access to tubular epithelial cells that could potentially inform on physiological regulation of transporter activity in human kidneys . The proteins that are present in urine are a major area of investigation for proteomics researchers. In normal urine, typically half of the proteins are soluble proteins (49%), and the remaining 48% are sediment precipitated with low-speed centrifugation, and exosomes (3%). All exosomes contain a few common protein components. The cytosolic proteins present on exosomes include annexins, adhesion molecules, proteins that participate in vesicle formation and trafficking and metabolic enzymes. Analysis of urine exosomes can enhance the detectability of relatively low-abundant proteins that have potential pathophysiological significance, and so have become one of the newer trends in the field of urine-biomarker discovery .
Volunteers with hypertension stage 1, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization blood and urine samples will be collected daily, as well as clinical parameters such as blood pressure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study assesses how nutritional changes, namely DASH diet, change the composition of ion channels in the renal tubule, as exemplified by urine electrolyte ratio.
| Arm | Type | Receives |
|---|---|---|
| nutrition implementation | Experimental | Other: DASHVolunteers with prehypertension, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization we will: 1) collect samples of blood and urine daily 2) monitor blood pressure, weight and pulse twice daily 3) collect 24-hour urine, twice during the period of two weeks 4) serve participants a menu based on DASH principles, namely low in sodium and high in potassium. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- any gender, 18-60 years of age
- self described as White or Black individuals
- prehypertensives (=stage 1 hypertension) defined as sustolic blood pressure of 130-159 mmHG and/or diastolic blood pressure between 80-100.
- adequate dentition to consume fruits and vegetables as described for DASH -
Key exclusion criteria (16 listed)
- Preexisting kidney disease structural or parenchymal including APCKD (adult polycystic kidney disease), single kidney (as assessed by ultrasound including size differences >3 cm in diameter between kidneys), or evidence of RAS (renal artery stenosis)
- Pregnant
- HIV
- taking medications for diabetes, hyperlipidemia, cardiac disease, Medications for birth control, psychiatirc conditions, and sleep are Ok. Vitamins and herbs are Ok if continued throughout the study. Thyroid meds are acceptable if the TSH is within normal limits.
- Diabetes as defined by hemoglobin A1c > 6.5% and/or fasting glucose > 125 mg/dl
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 |
|---|---|---|
| DASHDASH diet is based on low salt, high potassium components, and is comprised of mainly fruits and vegetables. During hospitalization we will collect laboratory data of blood and urine, and follow participants clinically by measuring blood pressure. | Other | nutrition implementation |
Primary outcome
urine exosome protein abundance pattern
Time frame: Day 1 and Day 12
Mass spectrometry generates a list of proteins for each sample. We will compare fold of change before (Day 1) and after intervention (Day 12) - a true change is defined as 1.5 fold.
urine electrolyte ratio in a spot urine as a surrogate to 24-h urine collection to assess nutritional consumption.
Time frame: day 1,2,3,4,5,6,8,9,10,11,12,14
spot urine will be analyzed for sodium and potassium parallel to 24-h urine collection. We will assess the concordance between the 24-h collection and the spot urine ratio of electrolytes. The result will be presented as a ratio of SPOT ratio (sodium/potassium) to 24-h collection ratio (sodium/potassium), for each participant. We will assess how close the ratio of ratios is to one.
24-h urine collection as a measure of adherence to the DASH diet
Time frame: day 1, 12
Urine will be collected throughout 24 hours to analyze electrolyte content, during intervention - twice, at the beginning (day 1) and end of intervention (day 12). We will be measuring daily sodium excretion, the threshold for compliance will be equal to or less than 100MEQ/d. For potassium daily excretion the threshold will be greater than or equal to 90meq/d . The change will be reported as number of participants that have met the defined threshold for compliance.
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 5 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Dana Bielopolski, MD PhD principal investigator
The Rockefeller 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 in people with Prehypertension, run by Rockefeller 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 4 inclusion and 16 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 5 Aug 2021. 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?
urine exosome protein abundance pattern (time frame: Day 1 and Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2021.