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.
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,
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
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
Crossover
Potassium15
Dietary supplementImmediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
Potassium10
Dietary supplementImmediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
Plain Water
Other interventionImmediately 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 Punch
Other interventionImmediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
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
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
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)
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).
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).
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).
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in vital signs (blood pressure (systolic and diastolic)) and heart rate after supplementation
Change in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and heart rate (beats per minute) from screening through final study visit following supplementation.
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Chobani
Lead sponsor
KGK Science Inc.
Collaborator
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