32 Participants NeededMy employer runs this trial

Investigational Products for Dehydration

EL
Overseen ByErin Lewis, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new drinks, Potassium10 and Potassium15, to determine their effectiveness in hydration after exercise. Researchers aim to find out if these drinks outperform regular water or typical sports drinks in maintaining hydration. Participants will consume these beverages post-exercise, and their hydration levels will be monitored at various intervals. Individuals who regularly engage in intense exercise for 30 to 150 minutes a week and are willing to adhere to specific exercise and diet guidelines are ideal candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance hydration options for active individuals.

Do I have to stop taking my current medications for the trial?

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible. However, if you are taking medications or supplements that might affect body water regulation, you may need to stop them. It's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that potassium, the main ingredient in both Potassium10 and Potassium15, is generally safe for most people when taken in reasonable amounts. Studies have found that consuming up to 100 mEq (3900 mg) of potassium daily is likely safe for most individuals, as the body can handle these levels without serious side effects.

However, some people might experience minor issues like an upset stomach or diarrhea when taking potassium supplements. Those with certain health conditions, such as kidney problems, should be cautious with potassium intake, as excessive amounts can lead to muscle weakness or irregular heartbeats.

Evidence so far supports that potassium is well-tolerated by healthy adults. Both Potassium10 and Potassium15 are designed to aid hydration, and current data suggests they should be safe when used as directed by healthy individuals.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Potassium10 and Potassium15 because they offer a potentially more effective way to combat dehydration by using varied concentrations of potassium, a key electrolyte lost during dehydration. Most current treatments, like oral rehydration solutions and sports drinks, focus on balancing electrolytes and fluids, but these investigational treatments might optimize the potassium levels more precisely for better hydration outcomes. The potential for enhanced rehydration efficiency and quicker recovery times makes these treatments particularly promising for athletes and individuals in high-demand environments.

What evidence suggests that this trial's treatments could be effective for post-exercise hydration?

Studies have shown that drinks high in potassium can aid in rehydration after exercise. In this trial, participants may receive Potassium10, which research suggests helps the body retain fluids, crucial for maintaining hydration, especially when compared to plain water. Alternatively, participants may receive Potassium15, which works with sodium to balance the body's fluids and prevent dehydration. Researchers are studying both of these potassium-based drinks for their potential to enhance hydration, particularly for active individuals.23678

Who Is on the Research Team?

DC

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who regularly do moderate to hard aerobic exercise (30–150 minutes per week) and are physically fit for exercise. Women must not be able to become pregnant or agree to use reliable birth control. Participants must be willing to complete an exercise challenge.

Inclusion Criteria

4. Self-reported hard or very hard aerobic exercise of ≥30 and ≤150 minutes per week, as assessed by the Stanford 7-Day Physical Activity Recall at screening
My partner had a vasectomy at least 6 months ago.
I am between 18 and 65 years old.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-6 weeks

Treatment

Participants consume investigational products and control beverages, complete questionnaires, undergo an exercise challenge, and record food and beverage intake

4 visits
Visits 2 to 5

Follow-up

Participants are monitored for changes in blood hematocrit, serum osmolality, and other secondary measures post-exercise

8 hours post-exercise
Visits 2 to 5

What Are the Treatments Tested in This Trial?

Interventions

  • Potassium10
  • Potassium15

Trial Overview

The study compares two new potassium-based drinks (Potassium15 and Potassium10) with plain water and Gatorade Fruit Punch to see which best helps the body rehydrate after exercise. All participants will try each drink, answer questionnaires, and track their food and drink intake.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Potassium15Experimental Treatment1 Intervention
Group II: Potassium10Experimental Treatment1 Intervention
Group III: Marketed sports beverageActive Control1 Intervention
Group IV: WaterPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chobani

Lead Sponsor

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

Oral Rehydration Beverages for Treating Exercise-Associated ...

The presence of potassium in a drink may not be as effective as sodium in improving hydration status. Coconut water has been widely used in the ...

Effect of dehydration and acidemia on the potassium ...

The aim of this study was to investigate how intracellular K homeostasis is affected by dehydration and acidemia, the 2 most important metabolic disturbances in ...

Potassium - StatPearls - NCBI Bookshelf - NIH

Potassium is FDA-approved to treat hypokalemia, a condition in which the serum potassium level falls below a critical range.

Potassium Disorders: Hypokalemia and Hyperkalemia

Hypokalemia and hyperkalemia occur when serum potassium levels are less than 3.5 mEq per L or greater than 5.0 mEq per L, respectively.

Potassium - Uses, Side Effects, and More

Potassium is most commonly used for treating and preventing low potassium levels, treating high blood pressure, and preventing stroke.

Potassium - Health Professional Fact Sheet

Potassium overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions ...

Potassium and Health

Adequate dietary potassium is important for heart and bone health and reduces the risk of stroke and coronary heart disease.

Evaluating the Severity of Reported Potassium-Related...

This study aimed to identify and describe potassium-related incidents reported in ICUs at the national level, and to investigate the consensus of an expert ...