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Electrolyte Supplement
Potassium + Water for High Blood Pressure (PHACKs Trial)
N/A
Recruiting
Research Sponsored by Auburn University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18-30 years
BMI below 35 kg/m2
Must not have
Have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention (14 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if adding a potassium supplement to water can improve hydration and cardiovascular health in young Black and White adults. Black adults are at a higher risk of cardiovascular disease and kidney disease due to
Who is the study for?
This trial is for young adults aged 18-30 with a BMI below 35, who don't have metabolic diseases like diabetes, kidney or lung issues, cardiovascular conditions, autoimmune disorders, or a history of cancer. They should also have a resting blood pressure no higher than 150/90 mmHg.
What is being tested?
The study tests if drinking water with added potassium (2000mg/day) can improve hydration and heart health better in Black adults compared to White adults. It involves taking urine and blood samples before and after a two-week period of this hydration strategy.
What are the potential side effects?
Possible side effects from high potassium intake include stomach discomfort, nausea, diarrhea or constipation. Overconsumption might lead to hyperkalemia which affects heart rhythm but is unlikely at the dose given.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Select...
My BMI is under 35.
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I do not have diabetes, kidney, lung, heart diseases, autoimmune conditions, or a history of cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions like hemophilia or take medications like Pradaxa that prevent blood donation.
Select...
I am not taking any medication that is unsafe with potassium supplements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention (14 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention (14 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
24-hour ambulatory blood pressure
Brachial blood pressure
Plasma copeptin
+5 moreSecondary study objectives
Blood glucose
Dietary intake
Inflammatory cytokine responses
+8 moreOther study objectives
Area deprivation index
Blood pressure reactivity responses
Hematocrit
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Water and PotassiumExperimental Treatment1 Intervention
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 citrate powder.
Group II: Habitual consumptionActive Control1 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.
Find a Location
Who is running the clinical trial?
Auburn UniversityLead Sponsor
80 Previous Clinical Trials
14,579 Total Patients Enrolled
Indiana UniversityOTHER
1,044 Previous Clinical Trials
1,316,829 Total Patients Enrolled
Austin T Robinson, Ph.D.Study DirectorIndiana University
L. Bruce Gladden, Ph.D.Study DirectorAuburn University