Effects of Oral Rehydration Solution on Dehydration Recovery in Adults

Abbott Nutrition1 site in 1 country9 target enrollmentJuly 8, 2024

Overview

This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution.

Registry

clinicaltrials.gov

Start Date

July 8, 2024

End Date

October 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•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 of \< 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 first study visit 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 is a current, and including 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 according to self-report:

Plasma Volume

Time Frame: Through Study completion, an average of 2 weeks

Calculated Change in Plasma Volume

Hydration Status Urine(Through Study completion, an average of 2 weeks)
Blood Biomarker - Plasma Osmolality(Through Study completion, an average of 2 weeks)
Body Mass(Through Study completion, an average of 2 weeks)
Blood Biomarker - Plasma Electrolyte Concentration(Through Study completion, an average of 2 weeks)
Blood Biomarker - Plasma Glucose Concentration(Through Study completion, an average of 2 weeks)
Body Temperature(Through Study Completion, as average of 2 weeks)