Oral Rehydration Solutions in Healthy Adult Athletes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control Group No intervention |
Other: Control Group
No intervention
|
| Experimental: Oral Rehydration Solution 1 ORS with high level carbohydrate |
Other: Oral Rehydration Solution 1
Participants will be administered ORS 1 during one of the study visits
|
| Experimental: Oral Rehydration Solution 2 ORS with low level carbohydrate |
Other: Oral Rehydration Solution 2
Participants will be administered ORS 2 during one of the study visits
|
| Experimental: Water Water with flavor |
Other: Water
Participants will be administered water during one of the study visits
|
Outcome Measures
Primary Outcome Measures
- Anaerobic Power [Through Study completion, an average of 6 weeks]
Change in cycling power
Secondary Outcome Measures
- 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)
- Leg Strength [Through Study completion, an average of 6 weeks]
Measured by dynamometer
- Muscular Force [Through Study completion, an average of 6 weeks]
Change in isometric muscular contractions
Other Outcome Measures
- Reaction Time [Through Study completion, an average of 6 weeks]
Change in reaction time
- 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
- 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
- Heart Rate [Through Study completion, an average of 6 weeks]
Change in heart rate
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 to 30 years of age.
-
Body fat percentage ≤15% for males and ≤20% for females.
-
Male or non-pregnant, non-lactating female, at least 6 months postpartum prior to screening visit.
-
Normotensive with blood pressure ≤ 120/80 mm Hg, without the use of anti-hypertensive medications.
-
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.
-
Willing to consume grape-flavored beverages during the study.
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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.
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Currently taking or has taken a diuretic within 1 week of enrollment.
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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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kent State University | Kent | Ohio | United States | 44240 |
Sponsors and Collaborators
- Abbott Nutrition
Investigators
- Study Chair: Jennifer Williams, MPH, Abbott Nutrition
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BL67