Clinical trial NCT05569044: Oral Rehydration Solutions in Healthy Adult Athletes
Official title: Effects of Oral Rehydration Solutions in Healthy Adult Athletes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hydration
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anaerobic Power
timeFrame: Through Study completion, an average of 6 weeks
Secondary outcomes:
measure: Body Mass
timeFrame: Through Study completion, an average of 6 weeks
measure: Power Output
timeFrame: Through Study completion, an average of 6 weeks
measure: Rating of Perceived Exertion (RPE)
timeFrame: Through Study completion, an average of 6 weeks
measure: Leg Strength
timeFrame: Through Study completion, an average of 6 weeks
measure: Muscular Force
timeFrame: Through Study completion, an average of 6 weeks
Other outcomes:
measure: Reaction Time
timeFrame: Through Study completion, an average of 6 weeks
measure: Muscular Endurance
timeFrame: Through Study completion, an average of 6 weeks
measure: Muscular Strength
timeFrame: Through Study completion, an average of 6 weeks
measure: Hydration Status Plasma
timeFrame: Through Study completion, an average of 6 weeks
measure: Hydration Status Urine
timeFrame: Through Study completion, an average of 6 weeks
measure: Hydration Status Saliva
timeFrame: Through Study completion, an average of 6 weeks
measure: Blood Biomarkers Creatinine
timeFrame: Through Study completion, an average of 6 weeks
measure: Blood Biomarkers Cytokines
timeFrame: Through Study completion, an average of 6 weeks
measure: Blood Biomarkers Glucose
timeFrame: Through Study completion, an average of 6 weeks
measure: Blood Biomarkers Insulin
timeFrame: Through Study completion, an average of 6 weeks
measure: Body Temperature
timeFrame: Through Study completion, an average of 6 weeks
measure: Heart Rate
timeFrame: Through Study completion, an average of 6 weeks
measure: Profile of Mood States
timeFrame: Through Study completion, an average of 6 weeks
measure: Thirst Sensation Scale
timeFrame: Through Study completion, an average of 6 weeks
measure: Gagge Thermal Scale
timeFrame: Through Study completion, an average of 6 weeks
measure: Palatability
timeFrame: Through Study completion, an average of 6 weeks
measure: Adverse Events
timeFrame: Through Study completion, an average of 6 weeks
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References: