Oral Rehydration Solutions in Healthy Adult Athletes

NCT05569044 | Terminated

• 1 other identifier: BL67
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration

Outcome Measures

Primary Outcomes (1)

• Anaerobic Power

  Change in cycling power

  Through Study completion, an average of 6 weeks

Secondary Outcomes (5)

• Body Mass

  Through Study completion, an average of 6 weeks

• Power Output

  Through Study completion, an average of 6 weeks

• Rating of Perceived Exertion (RPE)

  Through Study completion, an average of 6 weeks

• Leg Strength

  Through Study completion, an average of 6 weeks

• Muscular Force

  Through Study completion, an average of 6 weeks

Other Outcomes (17)

• Reaction Time

  Through Study completion, an average of 6 weeks

• Muscular Endurance

  Through Study completion, an average of 6 weeks

• Muscular Strength

  Through Study completion, an average of 6 weeks

Study Arms (3)

Control Group

OTHER

No intervention

Other: Control Group

Oral Rehydration Solution

EXPERIMENTAL

ORS with carbohydrate

Other: Oral Rehydration Solution

Water

EXPERIMENTAL

Water with flavor

Other: Water

Interventions

Control Group OTHER

No intervention

Control Group

Oral Rehydration Solution OTHER

Participants will be administered ORS during one of the study visits

Oral Rehydration Solution

Water OTHER

Participants will be administered water during one of the study visits

Water

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Kent State University

Kent, Ohio, 44240, United States

Location

MeSH Terms

Interventions

Control Groups; World Health Organization oral rehydration solution; Water

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Jennifer Williams, MPH

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 6, 2022
• Study Start: November 21, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)