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

NCT06062017 | Recruiting

• 1 other identifier: #23-381
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Urine specific gravity

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

  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)

  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).

  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

  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.

  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.

  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).

  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)

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

Secondary Outcomes (11)

• Kidney blood velocity

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

• Plasma Osmolality

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

• Plasma electrolytes

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

• Blood glucose

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

• Objective sleep duration

  Pre-intervention (14 days)

Other Outcomes (5)

• Hemoglobin

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

• Hematocrit

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

• Physical activity

  Pre-intervention (intake visit)

Study Arms (2)

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.

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.

Interventions

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.

Water and Potassium

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Auburn University: lead
• Indiana University: collaborator

Study Sites (1)

Kinesiology Building

Auburn, Alabama, 36849, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 37619651 BACKGROUND

• Fuller-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.

  PMID: 33798979 BACKGROUND

• Brooks 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.

  PMID: 28727528 BACKGROUND

• Onufrak 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.

  PMID: 23098620 BACKGROUND

• Onufrak 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.

  PMID: 24443781 BACKGROUND

• Park 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.

  PMID: 36609168 BACKGROUND

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Austin T Robinson, Ph.D.

  Indiana University

  STUDY DIRECTOR

• L. Bruce Gladden, Ph.D.

  Auburn University

  STUDY DIRECTOR

Central Study Contacts

Nina L Stute, M.S.

CONTACT

9373071608; NLS0028@auburn.edu

Meral A Culver, M.S.

CONTACT

3017428813

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking, open label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: After a two-week habitual consumption run-in participants will be assigned to two weeks of water and potassium supplementation.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 2, 2023
• Study Start: November 6, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 2 years after completion of the study, indefinitely
• Access Criteria: Unidentified individual participant data will be made available to other researchers upon reasonable request and data and completion of a material transfer agreement with Auburn University.

Locations

US (1)