DehydrationNCT06130475
Oral Rehydration Solution in Healthy Adults
A study testing Oral Rehydration Solution (ORS) and Water in people with Dehydration, run by Abbott Nutrition at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled, blinded, crossover study to evaluate the effects of an oral hydration solution. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Oral Rehydration Solution (ORS) and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 16 Dec 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: 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.
- Conditions
- Dehydration
- Being tested
- Oral Rehydration Solution (ORS), Water
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehydration Solution (ORS)Other
Participants will be administered the ORS during one of the study visits
WaterOther
Participants will be administered water during one of the study visits
| Study group | Role | What they receive |
|---|---|---|
| Oral Rehydration Solution | Experimental | Oral rehydration solution with carbohydrate Receives: Other: Oral Rehydration Solution (ORS) |
| Water | Experimental | Water with flavor Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Volume
Calculated Change in Plasma Volume
Measured: Through Study completion, an average of 2 weeks
Secondary outcomes (6)
Body Mass
Body Mass Loss
Measured: Through Study completion, an average of 2 weeks
Hydration Status Urine
Change in Urine Osmolality
Measured: Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Osmolality
Change in Plasma Osmolality
Measured: Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Electrolyte Concentration
Change in Electrolyte Concentration
Measured: Through Study completion, an average of 2 weeks
Blood Biomarker - Glucose Concentration
Change in Plasma Glucose Concentration
Measured: Through Study completion, an average of 2 weeks
Body Temperature
Change in degrees Celsius
Measured: Through Study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start15 Mar 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130475
- Sponsor's protocol ID
- BL68
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Rehydration Solution on Dehydration Recovery in Adults
- ClinicalTrials.gov ID
- NCT06130475
- Acronym / sponsor ID
- BL68
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 14 Nov 2023 (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.
This is a prospective, randomized, controlled, blinded, crossover study to evaluate the effects of an oral hydration solution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Rehydration Solution | Experimental | Other: Oral Rehydration Solution (ORS)Oral rehydration solution with carbohydrate |
| Water | Experimental | Other: WaterWater with flavor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Oral Rehydration Solution (ORS)Participants will be administered the ORS during one of the study visits | Other | Oral Rehydration Solution |
| WaterParticipants will be administered water during one of the study visits | Other | Water |
Primary outcome
Plasma Volume
Time frame: Through Study completion, an average of 2 weeks
Calculated Change in Plasma Volume
6 secondary outcomes
Body Mass
Time frame: Through Study completion, an average of 2 weeks
Hydration Status Urine
Time frame: Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Osmolality
Time frame: Through Study completion, an average of 2 weeks
Blood Biomarker - Plasma Electrolyte Concentration
Time frame: Through Study completion, an average of 2 weeks
Blood Biomarker - Glucose Concentration
Time frame: Through Study completion, an average of 2 weeks
Body Temperature
Time frame: Through Study completion, an average of 2 weeks
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 Jan 2025.
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration & Female Life Stages
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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.
Jennifer Williams study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Rehydration Solution (ORS) and Water in people with Dehydration, run by Abbott Nutrition 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 14 inclusion and 16 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 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Plasma Volume (time frame: Through Study completion, an average of 2 weeks). 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 Jan 2025.