Hydration
Conditions
Brief summary
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.
Interventions
OTHERControl Group
No intervention
Participants will be administered ORS during one of the study visits
OTHERWater
Participants will be administered water during one of the study visits
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 30 years of age. * Body fat percentage ≤17% for males and ≤24% for females. * Male or non-pregnant, non-lactating female, at least 6 months postpartum prior to screening visit. * Cycling VO2max in range of 45-53 mL O2/kg/min for males or 36-43 mL O2/kg/min for females. * If female, participant has a regular menstrual cycle, \>21 days and \<35 days in length. * Willing to consume grape-flavored beverages during the study. * If on chronic medication such as lipid-lowering, thyroid medication or hormone therapy, the dosage must be constant for at least 2 months prior to screening and baseline visit. * Weight-stable for the two months prior to screening visit * Voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study. * No known intolerance or allergy to ingredients in study products. * Willing to refrain from using saunas or hot tubs for the duration of the study. * Willing to follow study procedures and complete any forms or assessments needed during the study.
Exclusion criteria
* Athlete in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts. * 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. * Participating in another study that has not been approved as a concomitant study. * Uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician. * Previous history with heat illness or injury that resulted in a visit to a medical center. * Experienced a serious musculoskeletal injury or surgery in the past 6 months that poses a risk during the trial, according to the study investigator. * 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. * Currently taking or has taken antibiotics within 6 weeks of enrollment. * Currently taking or has taken a diuretic within 1 week of enrollment. * Diagnosed with the following according to medical records, self-report or according to the clinician's judgment: * Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis * Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis * Cardiovascular, metabolic \[including diabetes\], renal, hepatic, or respiratory disease * Active malignancy * Polycystic ovary disease * Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anaerobic Power | Through Study completion, an average of 6 weeks | Change in cycling power |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leg Strength | Through Study completion, an average of 6 weeks | Measured by dynamometer |
| Body Mass | Through Study completion, an average of 6 weeks | Body mass loss |
| Power Output | Through Study completion, an average of 6 weeks | Mean cycling power |
| Rating of Perceived Exertion (RPE) | Through Study completion, an average of 6 weeks | Participant completed scale of perceived exertion from 6 (no exertion at all) to 20 (maximum exertion) |
| Muscular Force | Through Study completion, an average of 6 weeks | Change in isometric muscular contractions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Biomarkers Creatinine | Through Study completion, an average of 6 weeks | Change in concentrations of creatinine |
| Blood Biomarkers Cytokines | Through Study completion, an average of 6 weeks | Change in concentrations of cytokines |
| Blood Biomarkers Glucose | Through Study completion, an average of 6 weeks | Change in concentrations of glucose |
| Blood Biomarkers Insulin | Through Study completion, an average of 6 weeks | Change in concentrations of insulin |
| Body Temperature | Through Study completion, an average of 6 weeks | Change in degrees Celsius |
| Reaction Time | Through Study completion, an average of 6 weeks | Change in reaction time |
| Profile of Mood States | Through Study completion, an average of 6 weeks | Participant completed questionnaire of 35 feelings rated from 0 (not at all) to 4 (extremely) |
| Thirst Sensation Scale | Through Study completion, an average of 6 weeks | Participant completed thirst question related from 1 (not thirsty at all) to 7 (very, very thirsty) |
| Gagge Thermal Scale | Through Study completion, an average of 6 weeks | Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot) |
| Palatability | Through Study completion, an average of 6 weeks | 3 participant completed Likert scale questions scored from 1 (Dislike/Not at all) to 9 (Extremely) |
| Adverse Events | Through Study completion, an average of 6 weeks | Participant experienced adverse events |
| Heart Rate | Through Study completion, an average of 6 weeks | Change in heart rate |
| Muscular Endurance | Through Study completion, an average of 6 weeks | Measured by dynamometer |
| Muscular Strength | Through Study completion, an average of 6 weeks | Change in hand grip strength |
| Hydration Status Plasma | Through Study completion, an average of 6 weeks | Change in plasma osmolality |
| Hydration Status Urine | Through Study completion, an average of 6 weeks | Change in urine osmolality |
| Hydration Status Saliva | Through Study completion, an average of 6 weeks | Change in saliva osmolality |
Countries
United States
Outcome results
None listed