Recruiting

Potassium & Hydration

Sponsor:

Auburn University

Code:

NCT06062017

Conditions

Blood Pressure

Hydration

Vascular Disease Risk

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Water and Potassium supplementation

Study Details

Brief 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. 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).

Conditions

Blood Pressure

Hydration

Vascular Disease Risk

Study ID

NCT06062017

Start date

Nov 6, 2024

Status verified date

Feb, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Water and Potassium

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.

no intervention: Habitual consumption

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.

Interventions

Water and Potassium supplementation

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.

Primary outcome measure

  • Urine specific gravity [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Urine osmolality [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Urine flow rate [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Plasma copeptin [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • 24-hour ambulatory blood pressure [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Pulse wave velocity [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Pulse wave analysis [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]
  • Brachial blood pressure [ Time Frame: Change score from habitual consumption to after the hydration interventions (2 weeks) ]

Central Contacts and Locations

Central contacts

Meral A Culver, M.S.

3017428813

Locations

Kinesiology Building

Recruiting

Auburn, Alabama, United States, 36849

Contacts

More Information

Sponsor

Auburn University

Last update posted

Feb 27, 2025

Last verified

Feb, 2025

Keywords

  • Racial disparities
  • Hydration
  • Blood pressure
  • Vascular function
  • Potassium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Auburn University on 2025-02-27.