Oral Rehydration Solution in Healthy Adults

Effects of Oral Rehydration Solution on Dehydration Recovery in Adults

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dehydration
• Intervention / Treatment: Other: Water; Other: Oral Rehydration Solution (ORS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 is normotensive without the use of antihypertensive 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water; Water with flavor	Other: Water; Participants will be administered water during one of the study visits
Experimental: Oral Rehydration Solution; Oral rehydration solution with carbohydrate	Other: Oral Rehydration Solution (ORS); Participants will be administered the ORS during one of the study visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Volume	Calculated Change in Plasma Volume	Through Study completion, an average of 2 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Fat	Change in Body Fat Composition as measured by Bioimpedance Analyzer	Through Study completion, an average of 2 weeks
Body Water	Change in Body Water as measured by Bioimpedance Analyzer	Through Study completion, an average of 2 weeks
Reaction Time	Change in Reaction Time	Through Study completion, an average of 2 weeks
Handgrip Strength	Change in Handgrip Strength measured via Hand Dynamometer	Through Study completion, an average of 2 weeks
Urine Volume	Urine Collection	Through Study completion, an average of 2 weeks
Hydration Status Saliva	Change in Saliva Osmolality	Through Study completion, an average of 2 weeks
Heart Rate	Change in Heart Rate as measured beats per minute	Through Study completion, an average of 2 weeks
Blood Pressure	Change in Blood Pressure as measured systolic/diastolic mm Hg	Through Study completion, an average of 2 weeks
Thirst Sensation Scale	Participant completed categorical scale based on "not thirsty at all" to "very, very thirsty"	Through Study completion, an average of 2 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 2 weeks
Palatability	3 participant completed palatability questions on Likert scale scored from 1 (Dislike/Not at all) to 9 (Extremely)	Through Study completion, an average of 2 weeks
Adverse Events	Participant Experienced Adverse Events	Through Study completion, an average of 2 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: BL68

Drug and device information, study documents

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