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This is a prospective, randomized, controlled, blinded, crossover study to evaluate the effects of an oral hydration solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Rehydration Solution | Experimental | Oral rehydration solution with carbohydrate |
|
| Water | Experimental | Water with flavor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Rehydration Solution (ORS) | Other | Participants will be administered the ORS during one of the study visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Volume | Calculated Change in Plasma Volume | Through Study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass | Body Mass Loss | Through Study completion, an average of 2 weeks |
| Hydration Status Urine | Change in Urine Osmolality | Through Study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Fat | Change in Body Fat Composition as measured by Bioimpedance Analyzer | Through Study completion, an average of 2 weeks |
| Body Water | Change in Body Water as measured by Bioimpedance Analyzer |
Inclusion Criteria:
Exclusion Criteria:
Participant is a current or recent (the past 8 weeks) participant in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts, with participation defined as ≥ 3x weekly training
Participant is currently, and for the past 4 weeks or longer: running >40 miles per week on average, cycling >80 miles per week on average or swimming >20,000 yards per week on average
Participant is participating in another study that has not been approved as a concomitant study
Participant has used a sauna in the past 4 weeks
Participant uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician
Participant has previous history with heat illness or injury that resulted in a visit to a medical center in the past 12 months
Participant has an eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
Participant is currently taking or has taken antibiotics within 6 weeks of enrollment
Participant is currently taking or has taken a diuretic within 1 week of enrollment
Participant has been diagnosed with the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Williams | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Florida | Orlando | Florida | 32816 | United States |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C044142 | World Health Organization oral rehydration solution |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Water | Other | Participants will be administered water during one of the study visits |
|
| Blood Biomarker - Plasma Osmolality | Change in Plasma Osmolality | Through Study completion, an average of 2 weeks |
| Blood Biomarker - Plasma Electrolyte Concentration | Change in Electrolyte Concentration | Through Study completion, an average of 2 weeks |
| Blood Biomarker - Glucose Concentration | Change in Plasma Glucose Concentration | Through Study completion, an average of 2 weeks |
| Body Temperature | Change in degrees Celsius | Through Study completion, an average of 2 weeks |
| Through Study completion, an average of 2 weeks |
| Reaction Time | Change in Reaction Time | Through Study completion, an average of 2 weeks |
| Handgrip Strength | Change in Handgrip Strength measured via Hand Dynamometer | Through Study completion, an average of 2 weeks |
| Urine Volume | Urine Collection | Through Study completion, an average of 2 weeks |
| Hydration Status Saliva | Change in Saliva Osmolality | Through Study completion, an average of 2 weeks |
| Heart Rate | Change in Heart Rate as measured beats per minute | Through Study completion, an average of 2 weeks |
| Blood Pressure | Change in Blood Pressure as measured systolic/diastolic mm Hg | Through Study completion, an average of 2 weeks |
| Thirst Sensation Scale | Participant completed categorical scale based on "not thirsty at all" to "very, very thirsty" | Through Study completion, an average of 2 weeks |
| Gagge Thermal Scale | Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot) | Through Study completion, an average of 2 weeks |
| Palatability | 3 participant completed palatability questions on Likert scale scored from 1 (Dislike/Not at all) to 9 (Extremely) | Through Study completion, an average of 2 weeks |
| Adverse Events | Participant Experienced Adverse Events | Through Study completion, an average of 2 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |