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

NCT07564661 | Not Yet Recruiting

• 1 other identifier: 25CHKGC01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

Secondary Outcomes (11)

• Change in Mean Corpuscular Volume

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

• Change in Sodium

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

• Change in Potassium

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

• Change in Blood Urea Nitrogen

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

• Change in Urine Volume

  0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5

Other Outcomes (2)

• Incidence of post-emergent adverse events (AE)

  From screening (Day -45 to Day -7) through final study visit (Visit 5)

• Clinically relevant changes in vital signs (blood pressure (systolic and diastolic)) and heart rate after supplementation

  From screening (Day -45 to Day -7) through final study visit (Visit 5)

Study Arms (4)

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

Interventions

Potassium15 DIETARY_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.

Potassium15

Potassium10 DIETARY_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.

Potassium10

Plain Water OTHER

Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.

Water

Gatorade Fruit Punch OTHER

Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.

Marketed sports beverage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chobani: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N5Y 5V6, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Pending review, IPD will be made available to researchers who provide a methodologically sound proposal specifically identifying how the requested data will be used to achieve the specific research aims. Proposals should be directed to Carli.liguori@chobani.com. To gain access, data requestors will need to sign a data access agreement.

Locations

CA (1)