Fluid RetentionNCT05428774
Efficacy of Different Oral Rehydration Solutions on the Hydration Status of Healthy Males
A study testing Test product 1 and Test product 2 in people with Fluid Retention and Beverage Hydration Index, run by Liquid I.V. at 1 site in United States.
Trial summary
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fluid Retention, Beverage Hydration Index, Hydration Status
- What is being tested?
- Test product 1 and Test product 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jan 2023
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 18-35 years old at the time of screening. Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study. Participants must be able to read and understand study instructions and any other relevant study documents. Willing to following the lifestyle and dietary restrictions as detailed in the Information Sheet for study.
Who cannot join
- A history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. Consumption other nutritional supplements, performance enhancing drugs, and non-steroidal anti-inflammatory drugs (NSAIDs) during the clinical. Participant has any medical condition which alters fluid balance in the body as confirmed by a health history questionnaire. Following a dietary pattern which may alter our findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.). Women are excluded due to the variability of fluid retention during the menstrual cycle. Participant is not currently enrolled in another clinical study. Participant is consuming any medication which may alter fluid retention such as diuretics. The participant is an employee of the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency. Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes. The two test products for this study, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.
- Conditions
- Fluid Retention, Beverage Hydration Index, Hydration Status
- Being tested
- Test product 1, Test product 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product 1Other
Participants will receive TP1 during one experimental visit.
Test product 2Other
Participants will receive TP2 during one experimental visit.
PlaceboOther
Participants will receive placebo during one experimental visit.
| Study group | Role | What they receive |
|---|---|---|
| Test Product 1 | Experimental | Participants will consume test product 1 during one experimental visit. Receives: Other: Test product 1 |
| Test Product 2 | Experimental | Participants will consume test product 2 during one experimental visit. Receives: Other: Test product 2 |
| Placebo | Placebo comparator | Participants will consume placebo during one experimental visit. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beverage hydration index
The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via the beverage hydration index
Measured: Through study completion, average of 6 weeks
Hydration status
The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via urine specific gravity analysis.
Measured: Through study completion, average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid RetentionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquid I.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Lipscomb University
- Responsible party
- Sponsor
- Investigators
- Jeremy Townsend, PhD, Principal investigator, Lipscomb University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428774
- Sponsor's protocol ID
- Pilot
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Oral Rehydration Solutions on the Hydration Status of Healthy Males
- ClinicalTrials.gov ID
- NCT05428774
- Acronym / sponsor ID
- Pilot
- Conditions
- Fluid Retention, Beverage Hydration Index, Hydration Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Liquid I.V.University, hospital or other
- Collaborators
- Lipscomb University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Jun 2022 (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.
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency. Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes. The two test products for this study, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product 1 | Experimental | Other: Test product 1Participants will consume test product 1 during one experimental visit. |
| Test Product 2 | Experimental | Other: Test product 2Participants will consume test product 2 during one experimental visit. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will consume placebo during one experimental visit. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males 18-35 years old at the time of screening. Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study. Participants must be able to read and understand study instructions and any other relevant study documents. Willing to following the lifestyle and dietary restrictions as detailed in the Information Sheet for study.
Key exclusion criteria (1 listed)
- A history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. Consumption other nutritional supplements, performance enhancing drugs, and non-steroidal anti-inflammatory drugs (NSAIDs) during the clinical. Participant has any medical condition which alters fluid balance in the body as confirmed by a health history questionnaire. Following a dietary pattern which may alter our findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.). Women are excluded due to the variability of fluid retention during the menstrual cycle. Participant is not currently enrolled in another clinical study. Participant is consuming any medication which may alter fluid retention such as diuretics. The participant is an employee of the Sponsor.
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 |
|---|---|---|
| Test product 1Participants will receive TP1 during one experimental visit. | Other | Test Product 1 |
| Test product 2Participants will receive TP2 during one experimental visit. | Other | Test Product 2 |
| PlaceboParticipants will receive placebo during one experimental visit. | Other | Placebo |
Primary outcome
Beverage hydration index
Time frame: Through study completion, average of 6 weeks
The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via the beverage hydration index
Hydration status
Time frame: Through study completion, average of 6 weeks
The primary objective of this study is to investigate the efficacy of two different oral rehydration solutions on the hydration status in healthy males via urine specific gravity analysis.
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 25 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Fluid Retention
RecruitingPhase 2
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Fluid Retention Caused by Heart Failure
Active, not recruitingPhase 1
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
Fluid Retention Due to Heart Failure
Active, not recruiting
The Effect of Hydration Status on Substrate Oxidation at Rest and During Light and Moderate Exercise
Hydration Status, Substrate Metabolism During Exercise
RecruitingObservational study
GLP1 Fasting Status and Gastric Retention Using Gastric Ultrasound
Gastric Retention
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.
Jeremy Townsend, PhD principal investigator
Lipscomb University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product 1 and Test product 2 in people with Fluid Retention and Beverage Hydration Index, run by Liquid I.V. 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 1 inclusion and 1 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 25 Jan 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.
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?
Beverage hydration index (time frame: Through study completion, average of 6 weeks). The study lists 2 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 25 Jan 2023.