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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium15 | Experimental |
| |
| Potassium10 | Experimental |
| |
| Water | Placebo Comparator |
| |
| Marketed sports beverage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5 |
| Change in Sodium |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | 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 |
Inclusion Criteria:
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
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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | Recruiting | London | Ontario | N5Y 5V6 | Canada |
Individual participant data that underlie the results reported in published research will be shared after deidentification (test, tables, figures, and appendices)
Beginning 3 months and ending 5 years following article publication.
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.
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| 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. |
|
| 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. |
|
| 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. |
|
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). |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5 |
Change in systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and heart rate (beats per minute) from screening through final study visit following supplementation. |
| From screening (Day -45 to Day -7) through final study visit (Visit 5) |