Oral Rehydration Solutions in Healthy Adult Athletes

Effects of Oral Rehydration Solutions in Healthy Adult Athletes

This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.

Study Overview

• Status: Recruiting
• Conditions: Hydration
• Intervention / Treatment: Other: Control Group; Other: Water; Other: Oral Rehydration Solution

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen S DeLuca; Phone Number: 16145653522; Email: kristen.deluca@abbott.com

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44240
      • Recruiting
      • Kent State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; No intervention	Other: Control Group; No intervention
Experimental: Water; Water with flavor	Other: Water; Participants will be administered water during one of the study visits
Experimental: Oral Rehydration Solution; ORS with carbohydrate	Other: Oral Rehydration Solution; Participants will be administered ORS during one of the study visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaerobic Power	Change in cycling power	Through Study completion, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass	Body mass loss	Through Study completion, an average of 6 weeks
Power Output	Mean cycling power	Through Study completion, an average of 6 weeks
Rating of Perceived Exertion (RPE)	Participant completed scale of perceived exertion from 6 (no exertion at all) to 20 (maximum exertion)	Through Study completion, an average of 6 weeks
Leg Strength	Measured by dynamometer	Through Study completion, an average of 6 weeks
Muscular Force	Change in isometric muscular contractions	Through Study completion, an average of 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction Time	Change in reaction time	Through Study completion, an average of 6 weeks
Muscular Endurance	Measured by dynamometer	Through Study completion, an average of 6 weeks
Muscular Strength	Change in hand grip strength	Through Study completion, an average of 6 weeks
Hydration Status Plasma	Change in plasma osmolality	Through Study completion, an average of 6 weeks
Hydration Status Urine	Change in urine osmolality	Through Study completion, an average of 6 weeks
Hydration Status Saliva	Change in saliva osmolality	Through Study completion, an average of 6 weeks
Blood Biomarkers Creatinine	Change in concentrations of creatinine	Through Study completion, an average of 6 weeks
Blood Biomarkers Cytokines	Change in concentrations of cytokines	Through Study completion, an average of 6 weeks
Blood Biomarkers Glucose	Change in concentrations of glucose	Through Study completion, an average of 6 weeks
Blood Biomarkers Insulin	Change in concentrations of insulin	Through Study completion, an average of 6 weeks
Body Temperature	Change in degrees Celsius	Through Study completion, an average of 6 weeks
Heart Rate	Change in heart rate	Through Study completion, an average of 6 weeks
Profile of Mood States	Participant completed questionnaire of 35 feelings rated from 0 (not at all) to 4 (extremely)	Through Study completion, an average of 6 weeks
Thirst Sensation Scale	Participant completed thirst question related from 1 (not thirsty at all) to 7 (very, very thirsty)	Through Study completion, an average of 6 weeks
Gagge Thermal Scale	Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot)	Through Study completion, an average of 6 weeks
Palatability	3 participant completed Likert scale questions scored from 1 (Dislike/Not at all) to 9 (Extremely)	Through Study completion, an average of 6 weeks
Adverse Events	Participant experienced adverse events	Through Study completion, an average of 6 weeks

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jennifer Williams, MPH, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: BL67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No