Investigational Products for Dehydration
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume investigational products and control beverages, complete questionnaires, undergo an exercise challenge, and record food and beverage intake
Follow-up
Participants are monitored for changes in blood hematocrit, serum osmolality, and other secondary measures post-exercise
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chobani
Lead Sponsor
KGK Science Inc.
Industry Sponsor
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.
8.
journals.lww.com
journals.lww.com/journalpatientsafety/fulltext/9900/evaluating_the_severity_of_reported.449.aspxEvaluating 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 ...
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