HydrationPhase 1/2NCT05111392
Hydration Dynamics and Influence of Beverage Composition
A Phase 1/2 study testing Oral Rehydration Solution 1 and Oral Rehydration Solution 2 in people with Hydration and Fluid Retention, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration, Fluid Retention, Dehydration
- What is being tested?
- Oral Rehydration Solution 1 and Oral Rehydration Solution 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2021to 30 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a BMI of 18.5 to 29.9 kg/m2.
- Be normotensive (<120/80 mm Hg).
- Must be able to speak and read English.
- Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial.
- Fast for at least 8 hours prior to and through the study trial.
- Be able to abstain from alcohol for 48 h prior to each study.
- Be able to abstain from caffeine for 24 h prior to each study.
- If female, must have regular menstrual cycles, that are > 27 days and < 35 days in length.
Who cannot join
- Under 18 y of age or over 45 y of age.
- Have a BMI <18.5 or >30.
- Being pregnant.
- Lactating.
- Tobacco user.
- Have hypotension or hypertension.
Show all 12Show fewer
- Have any type of kidney disease or dysfunction.
- Have diabetes.
- Have any type of cardiovascular disease.
- Have been diagnosed with galactosemia.
- Females with irregular menstrual cycles.
- Females with polycystic ovary disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.
Read the detailed description
Using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. Comparisons will be made between beverages for indices of the rate of appearance of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster absorption (D2O appearance rate), and better overall hydration (expanded PV and higher modified BHI) will occur for beverages containing glucose and sodium compared to water. Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.
- Conditions
- Hydration, Fluid Retention, Dehydration
- Being tested
- Placebo, Oral Rehydration Solution 1, Oral Rehydration Solution 2
- Keywords
- Hydration, Deuterium oxide, Plasma osmolality, Sodium, Urine production, Fluid absorption, Euhydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Ingestion of one (1) liter of beverage with observation for 2 h
Oral Rehydration Solution 1Biological
Ingestion of one (1) liter of beverage with observation for 2 h
Oral Rehydration Solution 2Biological
Ingestion of one (1) liter of beverage with observation for 2 h
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Water Receives: Biological: Placebo |
| Oral rehydration solution 1 | Experimental | Beverage with 2.5% glucose with 45 mmol sodium/L. Receives: Biological: Oral Rehydration Solution 1 |
| Oral rehydration solution 2 | Experimental | Beverage with 1.7% glucose with 60 mmol sodium/L. Receives: Biological: Oral Rehydration Solution 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appearance of deuterium in the plasma for placebo
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Measured: 2 hours
Rate of appearance of deuterium in the plasma for oral rehydration solution 1.
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Measured: 2 hours
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Measured: 2 hours
Secondary outcomes (6)
Fluid retention for placebo
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Measured: 2 hours
Fluid retention for oral rehydration solution 1
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Measured: 2 hours
Fluid retention for oral rehydration solution 2
Measure fluid retention using the difference between ingested volume and cumulative urine excretion as a percentage of the ingested volume.
Measured: 2 hours
Change in plasma volume for placebo
Increase in plasma volume (water content of the blood) following ingestion of beverage
Measured: 2 hours
Change in plasma volume for oral rehydration solution 1
Increase in plasma volume (water content of the blood) following ingestion of beverage
Measured: 2 hours
Change in plasma volume for oral rehydration solution 2
Increase in plasma volume (water content of the blood) following ingestion of beverage
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start3 Sep 2021
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Mixed model.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig A. Horswill, University of Illinois Chicago
- Investigators
- Craig A Horswill, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111392
- Sponsor's protocol ID
- 2021-0823
- Other IDs
- Abbott Nutrition (EAS)
- Status last verified
- Jul 2023
- First submitted
- 4 Nov 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If shared, the main outcome variables will be posted.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration Dynamics and Influence of Beverage Composition
- ClinicalTrials.gov ID
- NCT05111392
- Acronym / sponsor ID
- 2021-0823
- Conditions
- Hydration, Fluid Retention, Dehydration
- Keywords
- Hydration, Deuterium oxide, Plasma osmolality, Sodium, Urine production, Fluid absorption, Euhydration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines interactions between fluid availability in the gut and fluid retention in the body. The relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. Healthy, euhydrated adults will be studied. The results will help establish formulations of beverages that sustain if not promote acute euhydration.
Detailed description
Using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 Liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/L, or a beverage with 1.7% glucose with 60 mmol sodium/L. Before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of D2O, Hb, Hct, osmolality, sodium, and glucose. The rate of appearance of D2O will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. Comparisons will be made between beverages for indices of the rate of appearance of D2O, the change in PV over time, and cumulative urine excreted. The cumulative urine produced will be used to calculate a modified BHI for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). We hypothesize faster absorption (D2O appearance rate), and better overall hydration (expanded PV and higher modified BHI) will occur for beverages containing glucose and sodium compared to water. Further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Mixed model.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboWater |
| Oral rehydration solution 1 | Experimental | Biological: Oral Rehydration Solution 1Beverage with 2.5% glucose with 45 mmol sodium/L. |
| Oral rehydration solution 2 | Experimental | Biological: Oral Rehydration Solution 2Beverage with 1.7% glucose with 60 mmol sodium/L. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Have a BMI of 18.5 to 29.9 kg/m2.
- Be normotensive (<120/80 mm Hg).
- Must be able to speak and read English.
- Be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial.
- Fast for at least 8 hours prior to and through the study trial.
Key exclusion criteria (12 listed)
- Under 18 y of age or over 45 y of age.
- Have a BMI <18.5 or >30.
- Being pregnant.
- Lactating.
- Tobacco user.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboIngestion of one (1) liter of beverage with observation for 2 h | Biological | Placebo |
| Oral Rehydration Solution 1Ingestion of one (1) liter of beverage with observation for 2 h | Biological | Oral rehydration solution 1 |
| Oral Rehydration Solution 2Ingestion of one (1) liter of beverage with observation for 2 h | Biological | Oral rehydration solution 2 |
Primary outcome
Rate of appearance of deuterium in the plasma for placebo
Time frame: 2 hours
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Rate of appearance of deuterium in the plasma for oral rehydration solution 1.
Time frame: 2 hours
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
Rate of appearance of deuterium in the plasma for oral rehydration solution 2.
Time frame: 2 hours
Measure the rate of fluid uptake by the gut using appearance of deuterium oxide, or D2O, in the blood after ingesting a fixed volume of placebo.
6 secondary outcomes
Fluid retention for placebo
Time frame: 2 hours
Fluid retention for oral rehydration solution 1
Time frame: 2 hours
Fluid retention for oral rehydration solution 2
Time frame: 2 hours
Change in plasma volume for placebo
Time frame: 2 hours
Change in plasma volume for oral rehydration solution 1
Time frame: 2 hours
Change in plasma volume for oral rehydration solution 2
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No. If shared, the main outcome variables will be posted.
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Hydration Status
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Horswill, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral Rehydration Solution 1 and Oral Rehydration Solution 2 in people with Hydration and Fluid Retention, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of appearance of deuterium in the plasma for placebo (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.