Oral Rehydration Solution in Healthy Adults

Not Applicable

Completed

• Conditions: Dehydration
• Interventions: Other: Oral Rehydration Solution (ORS); Other: Water

• Registration Number: NCT06130475
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Study Start: 2024-03-15
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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 <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 enrollment 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 has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided applicable privacy regulation authorization prior to any participation in the study
• Participant has no known intolerance or allergy to ingredients in study products
• Participant is willing to refrain from using saunas or hot tubs for the duration of the study
• Participant is able and willing to follow study procedures and complete any forms or assessments needed during the study

Exclusion Criteria

• Participant is a current or recent (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:

  • 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
  • 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral Rehydration Solution	Oral Rehydration Solution (ORS)	Oral rehydration solution with carbohydrate
Water	Water	Water with flavor

Primary Outcome Measures

Name	Time	Method
Plasma Volume	Through Study completion, an average of 2 weeks	Calculated Change in Plasma Volume

Secondary Outcome Measures

Name	Time	Method
Body Mass	Through Study completion, an average of 2 weeks	Body Mass Loss
Hydration Status Urine	Through Study completion, an average of 2 weeks	Change in Urine Osmolality
Body Temperature	Through Study completion, an average of 2 weeks	Change in degrees Celsius
Blood Biomarker - Plasma Electrolyte Concentration	Through Study completion, an average of 2 weeks	Change in Electrolyte Concentration
Blood Biomarker - Plasma Osmolality	Through Study completion, an average of 2 weeks	Change in Plasma Osmolality
Blood Biomarker - Glucose Concentration	Through Study completion, an average of 2 weeks	Change in Plasma Glucose Concentration

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States