Hydration StatusNCT07564661

A Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults

A study testing Potassium15, Potassium10 and Plain Water in people with Hydration Status, run by Chobani at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hydration Status
What is being tested?: Potassium15, Potassium10 and Plain Water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteCanada
Study dates: 1 May 2026to Oct 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females between 18 and 65 years of age
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 screening Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control 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:
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)
Double-barrier method
Intrauterine devices

Show all 18Show fewer

Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually active during the study
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 period
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 consent to participate in the study
Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Who cannot join

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, intolerance, or dietary restriction, including dairy sensitivity/intolerance, preventing consumption of investigational product, comparator/control ingredients, or standardized meal
Self-reported unstable weight for the past 3 months defined as having gained or lost more than 5% of body weight prior to baseline
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

Show all 26Show fewer

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
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 up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
Individuals with an autoimmune disease or are immune compromised as assessed by the QI
Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis 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 washout (3-day washout period) and abstain for the duration of the study period
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
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 consent
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

Trial locations and contacts

1 site in 1 country.

Canada1 site

KGK Science Inc.
London, Ontario, N5Y 5V6

Other trials in Canada

About this study

Official title: 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

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.

Conditions: Hydration Status
Being tested: Potassium15, Potassium10, Plain Water, Gatorade Fruit Punch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
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.
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.

Study groups in NCT07564661
Study group	Role	What they receive
Potassium15	Experimental	Not described Receives: Dietary Supplement: Potassium15
Potassium10	Experimental	Not described Receives: Dietary Supplement: Potassium10
Water	Placebo comparator	Not described Receives: Other: Plain Water
Marketed sports beverage	Active comparator	Not described Receives: Other: Gatorade Fruit Punch

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Blood Hematocrit
Change in blood hematocrit (L/L) 0.5-, 2-, 4-, and 8-hours post-exercise between each IP beverage and control beverages
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Serum Osmolality
Change in serum osmolality (mOsm/kg) 0.5-, 2-, 4-, and 8-hours post-exercise between each IP beverage and control beverages
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

Secondary outcomes (11)

Change in Mean Corpuscular Volume
Change in mean corpuscular volume (MCV, fL) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5)
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Sodium
Change in serum sodium concentration (mmol/L) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Potassium
Change in serum potassium concentration (mmol/L) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Blood Urea Nitrogen
Change in blood urea nitrogen (mg/dL) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Volume
Change in urine volume (mL) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Specific Gravity
Change in urine specific gravity at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Osmolality
Change in urine osmolality (mOsm/kg) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Body Weight
Change in body weight (kg) at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in intracellular water
Change in intracellular water (L), assessed by bioelectrical impedance analysis, at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in extracellular water
Change in extracellular water (L), assessed by bioelectrical impedance analysis, at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in total body water
Change in total body water (L), assessed by bioelectrical impedance analysis, at 0.5-, 2-, 4-, and 8-hours post-exercise following ingestion of each IP beverage compared with control beverages (Visits 2-5).
Measured: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 2026Oct 2026

First posted4 May 2026
Study start1 May 2026
Primary completionOct 2026 (estimated)
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hydration StatusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07564661
Sponsor's protocol ID: 25CHKGC01
Status last verified: Oct 2026
First submitted: 10 Apr 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in published research will be shared after deidentification (test, tables, figures, and appendices)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)

All Hydration Status trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07564661
Acronym / sponsor ID: 25CHKGC01
Conditions: Hydration Status
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 32 participants (estimated)
Lead sponsor: ChobaniIndustry (pharma, biotech, devices)
Collaborators: KGK Science Inc.
Study start: 1 May 2026 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Oct 2026 (estimated)
First posted: 4 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Potassium15	Experimental	Dietary Supplement: Potassium15
Potassium10	Experimental	Dietary Supplement: Potassium10
Water	Placebo comparator	Other: Plain Water
Marketed sports beverage	Active comparator	Other: Gatorade Fruit Punch

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Males and females between 18 and 65 years of age
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 screening Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control 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:
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

Key exclusion criteria (26 listed)

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, intolerance, or dietary restriction, including dairy sensitivity/intolerance, preventing consumption of investigational product, comparator/control ingredients, or standardized meal
Self-reported unstable weight for the past 3 months defined as having gained or lost more than 5% of body weight prior to baseline
Poor venous access as assessed by the QI
Unstable metabolic disease or chronic diseases as assessed by the QI

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Potassium15Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.	Dietary supplement	Potassium15
Potassium10Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.	Dietary supplement	Potassium10
Plain WaterImmediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.	Other	Water
Gatorade Fruit PunchImmediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.	Other	Marketed sports beverage

Primary outcome

Change in Blood Hematocrit
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in blood hematocrit (L/L) 0.5-, 2-, 4-, and 8-hours post-exercise between each IP beverage and control beverages
Change in Serum Osmolality
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in serum osmolality (mOsm/kg) 0.5-, 2-, 4-, and 8-hours post-exercise between each IP beverage and control beverages

11 secondary outcomes

Change in Mean Corpuscular Volume
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Sodium
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Potassium
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Blood Urea Nitrogen
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Volume
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Specific Gravity
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Urine Osmolality
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in Body Weight
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in intracellular water
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in extracellular water
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
Change in total body water
Time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in published research will be shared after deidentification (test, tables, figures, and appendices)

Related trials for Hydration Status

Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Crowley, MD principal investigator

KGK Science Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Potassium15, Potassium10 and Plain Water in people with Hydration Status, run by Chobani at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Blood Hematocrit (time frame: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07564661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.