Oral Rehydration Solutions in Healthy Adult Athletes

Hydration Clinical Trial

Official title:

Effects of Oral Rehydration Solutions in Healthy Adult Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569044
• Other study ID #: BL67
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Abbott Nutrition
• Contact: Kristen S DeLuca
• Phone: 16145653522
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydration

Intervention

Other:
• Control Group
No intervention
• Oral Rehydration Solution
Participants will be administered ORS during one of the study visits
• Water
Participants will be administered water during one of the study visits

Locations

Country	Name	City	State
United States	Kent State University	Kent	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reaction Time	Change in reaction time	Through Study completion, an average of 6 weeks
Other	Muscular Endurance	Measured by dynamometer	Through Study completion, an average of 6 weeks
Other	Muscular Strength	Change in hand grip strength	Through Study completion, an average of 6 weeks
Other	Hydration Status Plasma	Change in plasma osmolality	Through Study completion, an average of 6 weeks
Other	Hydration Status Urine	Change in urine osmolality	Through Study completion, an average of 6 weeks
Other	Hydration Status Saliva	Change in saliva osmolality	Through Study completion, an average of 6 weeks
Other	Blood Biomarkers Creatinine	Change in concentrations of creatinine	Through Study completion, an average of 6 weeks
Other	Blood Biomarkers Cytokines	Change in concentrations of cytokines	Through Study completion, an average of 6 weeks
Other	Blood Biomarkers Glucose	Change in concentrations of glucose	Through Study completion, an average of 6 weeks
Other	Blood Biomarkers Insulin	Change in concentrations of insulin	Through Study completion, an average of 6 weeks
Other	Body Temperature	Change in degrees Celsius	Through Study completion, an average of 6 weeks
Other	Heart Rate	Change in heart rate	Through Study completion, an average of 6 weeks
Other	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
Other	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
Other	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
Other	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
Other	Adverse Events	Participant experienced adverse events	Through Study completion, an average of 6 weeks
Primary	Anaerobic Power	Change in cycling power	Through Study completion, an average of 6 weeks
Secondary	Body Mass	Body mass loss	Through Study completion, an average of 6 weeks
Secondary	Power Output	Mean cycling power	Through Study completion, an average of 6 weeks
Secondary	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
Secondary	Leg Strength	Measured by dynamometer	Through Study completion, an average of 6 weeks
Secondary	Muscular Force	Change in isometric muscular contractions	Through Study completion, an average of 6 weeks