Potassium, Hydration, Cardiovascular, and Kidney Study (PHACKs)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorAuburn University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Renin-angiotensin-aldosterone system (RAAS) blockers: Candesartan , Eprosartan, Irbesartan, Losartan, Olmesartan, Telmisartan

Non -steroidal anti-inflammatory medications: Aspirin, Ibuprofen, Naproxen

Trial design

Design model

Single group

Treatments tested in this trial

  • Water and Potassium supplementation

    Dietary 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Water and PotassiumExperimental treatment 1 intervention
Group B: Habitual consumptionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Urine specific gravity

24 urine samples will be aliquoted and assessed for urine specific gravity (unitless)

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
2

Urine osmolality

24 urine samples will be aliquoted and assessed for urine osmolality in mOsm/kg (AI Osmometer 3D3)

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
3

Urine flow rate

24 urine samples will be assessed for urine flow rate based on urine volume and self-reported collection time (ml/min).

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
4

Plasma copeptin

Plasma copeptin concentration (picomoles per liter) from a resting blood draw

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)

Secondary outcomes

1

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.

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
2

Plasma Osmolality

Researchers will analyze blood samples for osmolarity (AI Osmometer 3D3)

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
3

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).

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
4

Blood glucose

Researchers will analyze whole blood samples for blood glucose concentration in milligrams per deciliter using Cholestech benchtop analyzer

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)

Other outcomes

1

Hemoglobin

Whole blood samples will be analyzed for hemoglobin concentration (HemoCue, radiometer)

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
2

Hematocrit

Whole blood samples will be analyzed for hematocrit as a percentage (Thermo Hematocrit Microcentrifuge).

Time frame
Change score from habitual consumption to after the hydration interventions (2 weeks)
3

Physical activity

Participants will wear an ActiGraph GT3X accelerometer for 14 days to objectively quantify steps taken per day.

Time frame
Pre-intervention (intake visit)
4

Area deprivation index

Investigators will measure participant's area deprivation index (ADI) based on their self-reported zip code. The ADI is a multidimensional assessment of a region's socioeconomic conditions. It is used to measure and quantify the level of deprivation or disadvantage experienced by residents in a specific geographical area. The composite score will be standardized to have a mean of 100 and a standard deviation of 20 to assist interpretation.

Time frame
Pre-intervention (intake visit)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Auburn University

Lead sponsor

Indiana University

Collaborator