Testing Potassium15 against a placebo for hydration status
Official title: A Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults
A Randomized, Triple-Blind, Comparator-Controlled, Cross-Over Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults
- 4 groups
- One site, in London
- Recruiting
Interventions (4)
- Other intervention
Potassium15
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
- Other intervention
Potassium10
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
- Other intervention
Plain Water
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
- Other intervention
Gatorade Fruit Punch
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario
Eligibility Criteria
See who this study is looking for44 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Males and females between 18 and 65 years of age
- +Individuals of child-bearing potential must have a negative baselineBaselineYour starting measurements, taken before treatment begins.Read more → urine pregnancy test and agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- +Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → Or,
- +Double-barrier method
- +Intrauterine devices
- +Vasectomy of partner at least 6 months prior to screening
- +Physically fit for exercise, as assessed by the Physical Activity Readiness Questionnaire (PAR-Q), and is willing and able to complete the exercise challenge throughout the study
- +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
- +Agrees to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit
- +Agrees to abstain from alcohol consumption for at least 48 hours prior to each clinic visit and caffeine consumption and physical exercise on the morning of each study visit
- +Agrees to adhere to the dietary guidelines for the duration of the study, inclusive of the run-in periodRun-in periodA short trial period before the study proper begins.Read more →
- +Agrees to maintain current lifestyle habits (diet, medications, supplements, and sleep) as much as possible throughout the study
- +Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- +Provided voluntary, written, informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
- +Healthy as determined by medical history as assessed by the Qualified InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (QI)
- +Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- +Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- +Abstinence and agrees to use contraception if planning on becoming sexually active during the study
Exclusion
- −Allergy, sensitivity, intolerance, or dietary restriction, including dairy sensitivity/intolerance, preventing consumption of investigational product, comparatorControl groupThe group a new treatment is measured against.Read more →/control ingredients, or standardized meal
- −Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- −Self-reported unstable weight for the past 3 months defined as having gained or lost more than 5% of body weight prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →
- −Poor venous access as assessed by the QI
- −Unstable metabolic disease or chronic diseases as assessed by the QI
- −Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- −Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- −Type I or Type II diabetes and diabetes insipidus
- −Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- −History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- −Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- −Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- −Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- −Use of prescribed medical cannabinoid products
- −Chronic use of THC products (\>2 times/week). Occasional users will be required to washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → (3-day washout period) and abstain for the duration of the study period
- −Alcohol intake average of \>2 standard drinks per day as assessed by the QI
- −Alcohol or drug abuse within the last 12 months
- −Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product by altering body water regulation (Sections 7.3.1 and 7.3.2)
- −Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- −Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- −Individuals who are cognitively impaired and/or who are unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
- −Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- −Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- −Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- −Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives Potassium15.
Registry label: A: Potassium15
Group B receives Potassium10.
Registry label: B: Potassium10
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Plain Water.
Registry label: C: Water
Group D, the comparison group, receives Gatorade Fruit Punch.
Registry label: D: Marketed sports beverage
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 32 people.
The study is currently expected to finish around August 2026.
The main measurement is taken over: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Blood Hematocrit — measured over 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5.
Change in Serum Osmolality — measured over 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07564661 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Potassium15Dietary supplement
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Potassium10Dietary supplement
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Plain WaterOther
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Gatorade Fruit PunchOther
Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5.
The study as a whole is currently expected to finish around 2026-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 32 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to explore the efficacy of two investigational products for promoting post-exercise hydration in recreationally active healthy adults. The main question it aims to answer is: Does consumption of each investigational product (IP) beverage, compared to control beverages, result in differences in blood hematocrit and serum osmolality at 0.5, 2, 4, and 8 hours post-exercise in recreationally active healthy adults? Researchers will compare two IPs to control beverages to see if the IPs are effective for supporting post-exercise hydration. Participants will be required to consume the IPs, as well as control beverages. Participants will also complete questionnaires, undergo an exercise challenge, and record their food and beverage intake.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.