Blood PressurePHACKsNCT06062017
Potassium, Hydration, Cardiovascular, and Kidney Study (PHACKs)
A study testing Water and Potassium supplementation in people with Blood Pressure and Hydration, run by Auburn University at 1 site in United States.
Trial summary
Compared with White Adults, Non-Hispanic Black Adults are at an elevated risk of developing cardiovascular disease (CVD) and end stage chronic-kidney disease (CKD), two of the leading causes of death in the United States. Inadequate hydration status is associated with risk factors for both CVD and CKD. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hydration, Vascular Disease Risk
- What is being tested?
- Water and Potassium supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-30 years
- Resting blood pressure no higher than 150/90 mmHg
- BMI below 35 kg/m2
- Free of any metabolic disease (e.g., diabetes) kidney disease, pulmonary disorders (e.g., COPD), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer.
Who cannot join
- Have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood.
- Are currently pregnant or trying to become pregnant.
- take any of the following medications that are contraindicated with potassium supplementation:
- Renin-angiotensin-aldosterone system (RAAS) blockers: Candesartan , Eprosartan, Irbesartan, Losartan, Olmesartan, Telmisartan
- Non -steroidal anti-inflammatory medications: Aspirin, Ibuprofen, Naproxen
- Non-selective beta-blockers: Pindolol, Penbutolol, Oxprenolol, Propranolol, Nadolol, Sotalol, Timolol, Tertatolol
- Calcineurin inhibitors: Cyclosporine
- Heparin (or other blood thinning medications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meral A Culver, M.S. contact
United States1 site, 1 recruiting
- Recruiting
Kinesiology Building
Auburn, Alabama, 36849
Nina L Stute, MS, 334-844-1619, nls0028@auburn.edu
About this study
Official title: The Effects of Water and Potassium Supplementation on Cardiovascular and Kidney Function in Young Adults
Compared with White Adults, Non-Hispanic Black Adults are at an elevated risk of developing cardiovascular disease (CVD) and end stage chronic-kidney disease (CKD), two of the leading causes of death in the United States. Inadequate hydration status is associated with risk factors for both CVD and CKD. Prior data show that Black individuals are less likely to be adequately hydrated when compared with their White counterparts. Further, socioeconomic factors have been shown to influence hydration practices. Inadequate hydration influences certain hormones that regulate blood volume and impact blood pressure, but increasing potassium intake may provide some positive effects on normalizing these hormones and blood pressure. Black adults, in particular, are more likely to consume less potassium, have inadequate hydration, and tend to have higher blood pressure. As such, there is a critical need for effective strategies to address racial disparities in hydration and resultant health consequences; as well as establish the role of socioeconomic factors contributing to hydration. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement will improve hydration and cardiovascular health in young White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males. The investigators will assess measures of blood pressure, arterial stiffness, and biomarkers in the urine and blood samples prior to and following a 14-day hydration intervention of 1) bottled water and 2) bottled water with potassium supplementation (2000mg potassium/day).
Read the detailed description
Compared with White adults, Non-Hispanic Black adults are at an elevated risk of developing cardiovascular disease (CVD) and end-stage chronic kidney disease (CKD) two of the leading causes of mortality in the United States (U.S.). Inadequate hydration status is associated with all-cause mortality and several risk factors for CVD and CKD including obesity, insulin resistance, hypertension, and metabolic syndrome. Prior data demonstrate Black American individuals are more likely to be hypohydrated (i.e., inadequately hydrated) when compared with White individuals. One study in emerging adults (18-25 years old) indicates that Black adults are more likely to be hypohydrated compared with White adults when assessed using gold-standard 24-hour urine collections. Socioeconomic factors influence hydration practices. For example, there are well-justified increased perceptions of unsafe tap water among racial and ethnic minorities. Indeed, the recent Flint, Michigan, and Jackson, Mississippi water crises have raised public awareness over these environmental injustices and ways to increase safe drinking water availability and access. However, there remains a critical need for empirical studies on 1) strategies to address racial disparities in hydration and resultant health consequences; and 2) the role socioeconomic factors in contributing to hydration.
Importantly, hypohydration is associated with increased production of arginine vasopressin (AVP), a peptide hormone produced in the hypothalamus that influences body water balance via anti-diuretic effects. Plasma copeptin is an established surrogate marker of circulating AVP concentration. Plasma copeptin is associated with incident type 2 diabetes, metabolic syndrome, the progression of CKD, and CVD. Some, but not all, studies have demonstrated racial differences in circulating AVP/copeptin. Further, prior studies that aimed at increasing water resulted in reductions in copeptin and improvements in cardiometabolic health. For example, in a cohort with high plasma copeptin, increased water intake also reduced fasting plasma glucose. In a cohort of adults with overweight and obesity, increased water or low-calorie beverage intake reduced fasting plasma glucose and contributed to modest weight loss. Lastly, over 90% of adults do not meet recommendations for potassium intake. Importantly, potassium improves blood pressure (BP), particularly in Black adults, who tend to consume less potassium and have higher BP. Yet, there remains a knowledge gap regarding whether hydration intervention(s) inclusive of water (with or without) potassium could attenuate racial disparities in hydration status and circulating AVP/copeptin. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement (2000mg/day) will improve hydration and cardiovascular health in White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males). The investigators will utilize three complementary specific aims to address the investigators' hypotheses:
Aim 1: Determine whether water with potassium supplementation improves hydration status and reduces circulating copeptin. The investigators hypothesize that water and potassium supplementation will improve hydration and renal biomarkers, including increased urine volume, and reduced urine specific gravity, urine osmolality, and plasma copeptin.
Aim 2: Determine whether water with potassium supplementation improves BP and vascular health. The investigators hypothesize that water and potassium supplementation will reduce resting laboratory BP and ambulatory BP (awake, asleep, and nocturnal BP dipping), and reduce arterial stiffness assessed via pulse wave velocity.
Aim 3: Determine whether socioeconomic factors are associated with hydration perceptions, knowledge, and practices. The investigators hypothesize that area deprivation index (ADI, i.e., more deprivation) will be associated with hydration perceptions (e.g., greater distrust of tap water) and inadequate hydration assessed by self-reported fluid intake and urine-specific gravity.
In summary, a knowledge gap remains in determining the underlying reasons for the consistently reported racial differences in hydration. To restate, the purpose of this study is to determine 1) whether prescribing water with potassium supplementation is efficacious at improving hydration and reducing plasma copeptin in Black and White adults; 2) whether improving hydration with supplemental potassium improves BP and vascular function in young Black and White adults; 3) Another area of innovation in the investigators' proposal is determining whether area deprivation index (ADI, i.e., more deprivation) is associated with and 3a) beliefs and practices around hydration and 3b) hydration status. 4) We also seek to determine whether the intervention leads to greater improvements in Black adults who are more likely to be underhydrated.
- Conditions
- Blood Pressure, Hydration, Vascular Disease Risk
- Being tested
- Water and Potassium supplementation
- Keywords
- Racial disparities, Hydration, Blood pressure, Vascular function, Potassium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water and Potassium supplementationDietary supplement
All Participants will be given cases of water and instructed to drink at least an extra 1L per day. Additionally, participants will be given 2000 mg of potassium via potassium chloride powder.
| Study group | Role | What they receive |
|---|---|---|
| Water and Potassium | Experimental | N=40, 20 males, 20 females. Following the two-week habitual run-in period, this group will receive 2000mg potassium supplementation/day for 14 days. This will be achieved by taking capsules filled with potassium chloride powder. Receives: Dietary Supplement: Water and Potassium supplementation |
| Habitual consumption | No intervention | N=40, 20 males, 20 females. All participants will be monitored after two weeks of habitual water and potassium prior to being assigned into two weeks of water and potassium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine specific gravity
24 urine samples will be aliquoted and assessed for urine specific gravity (unitless)
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Urine osmolality
24 urine samples will be aliquoted and assessed for urine osmolality in mOsm/kg (AI Osmometer 3D3)
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Urine flow rate
24 urine samples will be assessed for urine flow rate based on urine volume and self-reported collection time (ml/min).
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma copeptin
Plasma copeptin concentration (picomoles per liter) from a resting blood draw
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
24-hour ambulatory blood pressure
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Pulse wave velocity
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV meters per second). A high-fidelity transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as cm/s.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Pulse wave analysis
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) The sampling site is the brachial artery (upper alarm instrumented with a cuff for oscillometric sphygmomanometer). PWA will be expressed as a percentage (calculated as augmentation pressure divided by the pulse pressure).
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Brachial blood pressure
Seated rachial blood pressure will be measured triplicate after at least 5 minutes of rest using an oscillometric device (Suntech CT 40)
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Secondary outcomes (11)
Kidney blood velocity
Renal and segmental artery blood velocity will be assessed in the decubitis position using a high-frequency ultrasound probe, typically in the range of 3-5 MHz.Using Spectral Doppler, the peak systolic velocity (PSV) in the renal and segmental arteries will be measured.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma Osmolality
Researchers will analyze blood samples for osmolarity (AI Osmometer 3D3)
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma electrolytes
Researchers will analyze plasma samples for electrolytes (Na, K, Cl) concentration using the SmartLyte Electrolyte Analyzer. The unit of measure for Na, K, and Cl is millimoles per liter (mmol/L).
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Blood glucose
Researchers will analyze whole blood samples for blood glucose concentration in milligrams per deciliter using Cholestech benchtop analyzer
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Objective sleep duration
Philips actiwatch spectrum will be used to quantify sleep duration in hours. Participants will wear the watch units for 14 days. The investigators will assess sleep duration and cross-check actigraphy wear times with a sleep diary.
Measured: Pre-intervention (14 days)
Objective sleep efficiency
Philips actiwatch spectrum will be used to quantify the percentage of time in bed actually spent sleeping to calculate sleep efficiency.
Measured: Pre-intervention (14 days)
Subjective sleep duration
The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to assess sleep duration reflective of the one-month period leading into the study. The global PSQI score can range from 0 to 21 points, however, this outcome specifically refers to self-reported sleep duration in hours.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Subjective sleep quality
The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to assess perceived sleep quality reflective of the one-month period leading into the study. The global PSQI score can range from 0 to 21 points.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Urine electrolytes
Researchers will analyze 24-hour urine samples for electrolytes (Na, K, Cl) content using the SmartLyte Electrolyte Analyzer. The unit of measure for Na, K, and Cl is milliequivalents (mEq).
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Inflammatory cytokine responses
Plasma will be used for a multiplex to measure inflammatory cytokines tumor necrosis factor-alpha, interleukin-6, monocyte chemoattractant protein-1, and interleukin-1. These biomarkers will be measured by enzyme-linked immunosorbent assays (ELISAs) from R\&D.
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Dietary intake
The investigators will instruct participants to complete a diet log for 3 days which will be operationalized with Nutrition Data System for Research (NDSR).
Measured: Change score from habitual consumption to after the hydration interventions (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start6 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- After a two-week habitual consumption run-in participants will be assigned to two weeks of water and potassium supplementation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Principal investigator, Austin Robinson, Auburn University
- Investigators
- Austin T Robinson, Ph.D., Study director, Indiana UniversityL. Bruce Gladden, Ph.D., Study director, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062017
- Sponsor's protocol ID
- #23-381
- Acronym
- PHACKs
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified individual participant data will be made available to other researchers upon reasonable request and data and material transfer agreement
Publications
Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
PubMed 37619651Fuller-Rowell TE, Nichols OI, Robinson AT, Boylan JM, Chae DH, El-Sheikh M. Racial disparities in sleep health between Black and White young adults: The role of neighborhood safety in childhood. Sleep Med. 2021 May;81:341-349. doi: 10.1016/j.sleep.2021.03.007. Epub 2021 Mar 12.
PubMed 33798979Brooks CJ, Gortmaker SL, Long MW, Cradock AL, Kenney EL. Racial/Ethnic and Socioeconomic Disparities in Hydration Status Among US Adults and the Role of Tap Water and Other Beverage Intake. Am J Public Health. 2017 Sep;107(9):1387-1394. doi: 10.2105/AJPH.2017.303923. Epub 2017 Jul 20.
PubMed 28727528Onufrak SJ, Park S, Sharkey JR, Sherry B. The relationship of perceptions of tap water safety with intake of sugar-sweetened beverages and plain water among US adults. Public Health Nutr. 2014 Jan;17(1):179-85. doi: 10.1017/S1368980012004600. Epub 2012 Oct 26.
PubMed 23098620Onufrak SJ, Park S, Sharkey JR, Merlo C, Dean WR, Sherry B. Perceptions of tap water and school water fountains and association with intake of plain water and sugar-sweetened beverages. J Sch Health. 2014 Mar;84(3):195-204. doi: 10.1111/josh.12138.
PubMed 24443781Park S, Onufrak SJ, Cradock AL, Patel A, Hecht C, Blanck HM. Perceptions of Water Safety and Tap Water Taste and Their Associations With Beverage Intake Among U.S. Adults. Am J Health Promot. 2023 Jun;37(5):625-637. doi: 10.1177/08901171221150093. Epub 2023 Jan 6.
PubMed 36609168
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Water and Potassium Supplementation on Cardiovascular and Kidney Function in Young Adults
- ClinicalTrials.gov ID
- NCT06062017
- Acronym / sponsor ID
- PHACKs / #23-381
- Conditions
- Blood Pressure, Hydration, Vascular Disease Risk
- Keywords
- Racial disparities, Hydration, Blood pressure, Vascular function, Potassium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Oct 2023 (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.
Compared with White Adults, Non-Hispanic Black Adults are at an elevated risk of developing cardiovascular disease (CVD) and end stage chronic-kidney disease (CKD), two of the leading causes of death in the United States. Inadequate hydration status is associated with risk factors for both CVD and CKD. Prior data show that Black individuals are less likely to be adequately hydrated when compared with their White counterparts. Further, socioeconomic factors have been shown to influence hydration practices. Inadequate hydration influences certain hormones that regulate blood volume and impact blood pressure, but increasing potassium intake may provide some positive effects on normalizing these hormones and blood pressure. Black adults, in particular, are more likely to consume less potassium, have inadequate hydration, and tend to have higher blood pressure. As such, there is a critical need for effective strategies to address racial disparities in hydration and resultant health consequences; as well as establish the role of socioeconomic factors contributing to hydration. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement will improve hydration and cardiovascular health in young White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males. The investigators will assess measures of blood pressure, arterial stiffness, and biomarkers in the urine and blood samples prior to and following a 14-day hydration intervention of 1) bottled water and 2) bottled water with potassium supplementation (2000mg potassium/day).
Detailed description
Compared with White adults, Non-Hispanic Black adults are at an elevated risk of developing cardiovascular disease (CVD) and end-stage chronic kidney disease (CKD) two of the leading causes of mortality in the United States (U.S.). Inadequate hydration status is associated with all-cause mortality and several risk factors for CVD and CKD including obesity, insulin resistance, hypertension, and metabolic syndrome. Prior data demonstrate Black American individuals are more likely to be hypohydrated (i.e., inadequately hydrated) when compared with White individuals. One study in emerging adults (18-25 years old) indicates that Black adults are more likely to be hypohydrated compared with White adults when assessed using gold-standard 24-hour urine collections. Socioeconomic factors influence hydration practices. For example, there are well-justified increased perceptions of unsafe tap water among racial and ethnic minorities. Indeed, the recent Flint, Michigan, and Jackson, Mississippi water crises have raised public awareness over these environmental injustices and ways to increase safe drinking water availability and access. However, there remains a critical need for empirical studies on 1) strategies to address racial disparities in hydration and resultant health consequences; and 2) the role socioeconomic factors in contributing to hydration.
Importantly, hypohydration is associated with increased production of arginine vasopressin (AVP), a peptide hormone produced in the hypothalamus that influences body water balance via anti-diuretic effects. Plasma copeptin is an established surrogate marker of circulating AVP concentration. Plasma copeptin is associated with incident type 2 diabetes, metabolic syndrome, the progression of CKD, and CVD. Some, but not all, studies have demonstrated racial differences in circulating AVP/copeptin. Further, prior studies that aimed at increasing water resulted in reductions in copeptin and improvements in cardiometabolic health. For example, in a cohort with high plasma copeptin, increased water intake also reduced fasting plasma glucose. In a cohort of adults with overweight and obesity, increased water or low-calorie beverage intake reduced fasting plasma glucose and contributed to modest weight loss. Lastly, over 90% of adults do not meet recommendations for potassium intake. Importantly, potassium improves blood pressure (BP), particularly in Black adults, who tend to consume less potassium and have higher BP. Yet, there remains a knowledge gap regarding whether hydration intervention(s) inclusive of water (with or without) potassium could attenuate racial disparities in hydration status and circulating AVP/copeptin. Therefore, the investigators are seeking to test the investigators' central hypothesis that water with a potassium supplement (2000mg/day) will improve hydration and cardiovascular health in White adults (n = 20, 10 females, 10 males), and to a greater extent in young Black Adults (n = 20, 10 females, 10 males). The investigators will utilize three complementary specific aims to address the investigators' hypotheses:
Aim 1: Determine whether water with potassium supplementation improves hydration status and reduces circulating copeptin. The investigators hypothesize that water and potassium supplementation will improve hydration and renal biomarkers, including increased urine volume, and reduced urine specific gravity, urine osmolality, and plasma copeptin.
Aim 2: Determine whether water with potassium supplementation improves BP and vascular health. The investigators hypothesize that water and potassium supplementation will reduce resting laboratory BP and ambulatory BP (awake, asleep, and nocturnal BP dipping), and reduce arterial stiffness assessed via pulse wave velocity.
Aim 3: Determine whether socioeconomic factors are associated with hydration perceptions, knowledge, and practices. The investigators hypothesize that area deprivation index (ADI, i.e., more deprivation) will be associated with hydration perceptions (e.g., greater distrust of tap water) and inadequate hydration assessed by self-reported fluid intake and urine-specific gravity.
In summary, a knowledge gap remains in determining the underlying reasons for the consistently reported racial differences in hydration. To restate, the purpose of this study is to determine 1) whether prescribing water with potassium supplementation is efficacious at improving hydration and reducing plasma copeptin in Black and White adults; 2) whether improving hydration with supplemental potassium improves BP and vascular function in young Black and White adults; 3) Another area of innovation in the investigators' proposal is determining whether area deprivation index (ADI, i.e., more deprivation) is associated with and 3a) beliefs and practices around hydration and 3b) hydration status. 4) We also seek to determine whether the intervention leads to greater improvements in Black adults who are more likely to be underhydrated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After a two-week habitual consumption run-in participants will be assigned to two weeks of water and potassium supplementation.
| Arm | Type | Receives |
|---|---|---|
| Water and Potassium | Experimental | Dietary Supplement: Water and Potassium supplementationN=40, 20 males, 20 females. Following the two-week habitual run-in period, this group will receive 2000mg potassium supplementation/day for 14 days. This will be achieved by taking capsules filled with potassium chloride powder. |
| Habitual consumption | No intervention | –N=40, 20 males, 20 females. All participants will be monitored after two weeks of habitual water and potassium prior to being assigned into two weeks of water and potassium. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18-30 years
- Resting blood pressure no higher than 150/90 mmHg
- BMI below 35 kg/m2
- Free of any metabolic disease (e.g., diabetes) kidney disease, pulmonary disorders (e.g., COPD), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer.
Key exclusion criteria (8 listed)
- Have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood.
- Are currently pregnant or trying to become pregnant.
- take any of the following medications that are contraindicated with potassium supplementation:
- Renin-angiotensin-aldosterone system (RAAS) blockers: Candesartan , Eprosartan, Irbesartan, Losartan, Olmesartan, Telmisartan
- Non -steroidal anti-inflammatory medications: Aspirin, Ibuprofen, Naproxen
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 |
|---|---|---|
| Water and Potassium supplementationAll Participants will be given cases of water and instructed to drink at least an extra 1L per day. Additionally, participants will be given 2000 mg of potassium via potassium chloride powder. | Dietary supplement | Water and Potassium |
Primary outcome
Urine specific gravity
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
24 urine samples will be aliquoted and assessed for urine specific gravity (unitless)
Urine osmolality
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
24 urine samples will be aliquoted and assessed for urine osmolality in mOsm/kg (AI Osmometer 3D3)
Urine flow rate
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
24 urine samples will be assessed for urine flow rate based on urine volume and self-reported collection time (ml/min).
Plasma copeptin
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma copeptin concentration (picomoles per liter) from a resting blood draw
24-hour ambulatory blood pressure
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
Pulse wave velocity
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV meters per second). A high-fidelity transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as cm/s.
Pulse wave analysis
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) The sampling site is the brachial artery (upper alarm instrumented with a cuff for oscillometric sphygmomanometer). PWA will be expressed as a percentage (calculated as augmentation pressure divided by the pulse pressure).
Brachial blood pressure
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Seated rachial blood pressure will be measured triplicate after at least 5 minutes of rest using an oscillometric device (Suntech CT 40)
11 secondary outcomes
Kidney blood velocity
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma Osmolality
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Plasma electrolytes
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Blood glucose
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Objective sleep duration
Time frame: Pre-intervention (14 days)
Objective sleep efficiency
Time frame: Pre-intervention (14 days)
Subjective sleep duration
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Subjective sleep quality
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Urine electrolytes
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Inflammatory cytokine responses
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Dietary intake
Time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 37619651Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
- Background: PubMed 33798979Fuller-Rowell TE, Nichols OI, Robinson AT, Boylan JM, Chae DH, El-Sheikh M. Racial disparities in sleep health between Black and White young adults: The role of neighborhood safety in childhood. Sleep Med. 2021 May;81:341-349. doi: 10.1016/j.sleep.2021.03.007. Epub 2021 Mar 12.
- Background: PubMed 28727528Brooks CJ, Gortmaker SL, Long MW, Cradock AL, Kenney EL. Racial/Ethnic and Socioeconomic Disparities in Hydration Status Among US Adults and the Role of Tap Water and Other Beverage Intake. Am J Public Health. 2017 Sep;107(9):1387-1394. doi: 10.2105/AJPH.2017.303923. Epub 2017 Jul 20.
- Background: PubMed 23098620Onufrak SJ, Park S, Sharkey JR, Sherry B. The relationship of perceptions of tap water safety with intake of sugar-sweetened beverages and plain water among US adults. Public Health Nutr. 2014 Jan;17(1):179-85. doi: 10.1017/S1368980012004600. Epub 2012 Oct 26.
- Background: PubMed 24443781Onufrak SJ, Park S, Sharkey JR, Merlo C, Dean WR, Sherry B. Perceptions of tap water and school water fountains and association with intake of plain water and sugar-sweetened beverages. J Sch Health. 2014 Mar;84(3):195-204. doi: 10.1111/josh.12138.
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- Individual participant dataSharing planned: Yes. Unidentified individual participant data will be made available to other researchers upon reasonable request and data and material transfer agreement
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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.
Meral A Culver, M.S. contact
Austin T Robinson, Ph.D. study director
Indiana University
L. Bruce Gladden, Ph.D. study director
Auburn 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 Water and Potassium supplementation in people with Blood Pressure and Hydration, run by Auburn 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 8 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina L Stute, M.S. (9373071608, NLS0028@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine specific gravity (time frame: Change score from habitual consumption to after the hydration interventions (2 weeks)). The study lists 8 primary outcomes in all. 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 NCT06062017, which also lists 6 linked publications.
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 27 Feb 2025.