Oral Rehydration Solution and Dehydration Recovery

February 26, 2025 updated by: Abbott Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Finlay Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 has a systolic blood pressure of < 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 first study visit 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, and including 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 according to self-report:

    • Recent or current 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Volume
Time Frame: Through Study completion, an average of 2 weeks
Calculated Change in Plasma Volume
Through Study completion, an average of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hydration Status Urine
Time Frame: Through Study completion, an average of 2 weeks
Change in Urine Osmolality
Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Osmolality
Time Frame: Through Study completion, an average of 2 weeks
Change in Plasma Osmolality
Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Electrolyte Concentration
Time Frame: Through Study completion, an average of 2 weeks
Change in Electrolyte Concentration
Through Study completion, an average of 2 weeks
Body Mass
Time Frame: Through Study completion, an average of 2 weeks
Change in Body Mass
Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Glucose Concentration
Time Frame: Through Study completion, an average of 2 weeks
Change in Plasma Glucose Concentration
Through Study completion, an average of 2 weeks
Body Temperature
Time Frame: Through Study Completion, as average of 2 weeks
Change in degrees Celsius
Through Study Completion, as average of 2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaction Time
Time Frame: Through Study completion, an average of 2 weeks
Change in Reaction Time
Through Study completion, an average of 2 weeks
Urine Volume
Time Frame: Through Study completion, an average of 2 weeks
Urine Collection
Through Study completion, an average of 2 weeks
Hydration Status Saliva
Time Frame: Through Study completion, an average of 2 weeks
Change in Saliva Osmolality
Through Study completion, an average of 2 weeks
Blood Pressure
Time Frame: Through Study completion, an average of 2 weeks
Change in Blood Pressure as measured systolic/diastolic mm Hg
Through Study completion, an average of 2 weeks
Thirst Sensation Scale
Time Frame: Through Study completion, an average of 2 weeks
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
Time Frame: Through Study completion, an average of 2 weeks
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
Time Frame: Through Study completion, an average of 2 weeks
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
Time Frame: Through Study completion, an average of 2 weeks
Participant Experienced Adverse Events
Through Study completion, an average of 2 weeks
Body Composition
Time Frame: Through Study completion, an average of 2 weeks
Change in Body Composition as measured by Bioimpedance Analyzer
Through Study completion, an average of 2 weeks
Handgrip Strength
Time Frame: Through Study completion, an average of 2 weeks
Change in handgrip strength as measured by hand dynamometer
Through Study completion, an average of 2 weeks
Heart Rate
Time Frame: Through Study completion, an average of 2 weeks
Changes in heart rate as measured beats per minute
Through Study completion, an average of 2 weeks
Urine Color
Time Frame: Through Study completion, an average of 2 weeks
Participant reported color match of 8 possible categories.
Through Study completion, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jennifer Williams, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL72

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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