Dehydration
Conditions
Brief summary
This is a prospective, randomized, controlled, blinded, crossover study to evaluate the effects of an oral hydration solution.
Interventions
Participants will be administered the 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
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is 18 to 40 years of age. * Participant has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 * Participant reports having a moderate to heavy sweat rate when physically exerted or in extreme heat * Participant is male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. * Participant has a systolic blood pressure \<130 mm Hg and a diastolic blood pressure \< 90 mm Hg without the use of anti-hypertensive medications. * Participant reports no predisposing cardiovascular conditions. * If female, participant has a regular menstrual cycle * Participant is willing to consume grape-flavored beverages during the study. * If participant is on chronic medication the dosage must be constant for at least 2 months prior to enrollment and able to maintain medication, type and dose throughout duration of study * Participant is weight-stable for the two months prior to screening visit * Participant has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided applicable privacy regulation authorization prior to any participation in the study * Participant has no known intolerance or allergy to ingredients in study products * Participant is willing to refrain from using saunas or hot tubs for the duration of the study * Participant is able and willing to follow study procedures and complete any forms or assessments needed during the study
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: * 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 * 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 |
|---|---|---|
| Plasma Volume | Through Study completion, an average of 2 weeks | Calculated Change in Plasma Volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hydration Status Urine | Through Study completion, an average of 2 weeks | Change in Urine Osmolality |
| Blood Biomarker - Plasma Osmolality | Through Study completion, an average of 2 weeks | Change in Plasma Osmolality |
| Body Mass | Through Study completion, an average of 2 weeks | Body Mass Loss |
| Blood Biomarker - Glucose Concentration | Through Study completion, an average of 2 weeks | Change in Plasma Glucose Concentration |
| Body Temperature | Through Study completion, an average of 2 weeks | Change in degrees Celsius |
| Blood Biomarker - Plasma Electrolyte Concentration | Through Study completion, an average of 2 weeks | Change in Electrolyte Concentration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Through Study completion, an average of 2 weeks | Change in Blood Pressure as measured systolic/diastolic mm Hg |
| Thirst Sensation Scale | Through Study completion, an average of 2 weeks | Participant completed categorical scale based on not thirsty at all to very, very thirsty |
| Body Fat | Through Study completion, an average of 2 weeks | Change in Body Fat Composition as measured by Bioimpedance Analyzer |
| Palatability | Through Study completion, an average of 2 weeks | 3 participant completed palatability questions on Likert scale scored from 1 (Dislike/Not at all) to 9 (Extremely) |
| Adverse Events | Through Study completion, an average of 2 weeks | Participant Experienced Adverse Events |
| Gagge Thermal Scale | Through Study completion, an average of 2 weeks | Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot) |
| Body Water | Through Study completion, an average of 2 weeks | Change in Body Water as measured by Bioimpedance Analyzer |
| Reaction Time | Through Study completion, an average of 2 weeks | Change in Reaction Time |
| Handgrip Strength | Through Study completion, an average of 2 weeks | Change in Handgrip Strength measured via Hand Dynamometer |
| Urine Volume | Through Study completion, an average of 2 weeks | Urine Collection |
| Hydration Status Saliva | Through Study completion, an average of 2 weeks | Change in Saliva Osmolality |
| Heart Rate | Through Study completion, an average of 2 weeks | Change in Heart Rate as measured beats per minute |
Countries
United States
Outcome results
None listed