DehydrationNCT05428228
Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
A study testing TP1 and TP2 in people with Dehydration and Rehydration, run by Liquid I.V. at 1 site in United States.
Trial summary
The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Rehydration, Exercise Performance
- What is being tested?
- TP1 and TP2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Sep 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female participants who are between 18 and 49 years of age (inclusive). Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit. Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive). Exercise regularly as per physical activity guidelines for Americans [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period. Can maintain their exercise status at the beginning of the study throughout the study period. Can achieve a peak VO2 at screening that is at least 60% of their age and gender matched normative value per American College of Sports Medicine recommendations. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to have urine pregnancy test performed on each trial day. Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes. Weigh less than or equal to 80 pounds at any visits. Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1). Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than two standard alcoholic drinks per day. Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study. Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. Smoking tobacco products.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Memphis
Memphis, Tennessee, 38152
Richard Bloomer, PhD, 901-678-5638, rbloomer@memphis.edu
About this study
Official title: A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.
- Being tested
- TP1, TP2, Placebo
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP1Other
Participants will be administered TP1 during one of the experimental visits.
TP2Other
Participants will be administered TP2 during one of the experimental visits.
PlaceboOther
Participants will be administered placebo during one of the experimental visits.
| Study group | Role | What they receive |
|---|---|---|
| TP1 | Experimental | Participants will be administered TP1 during one of the experimental visits. Receives: Other: TP1 |
| TP2 | Experimental | Participants will be administered TP2 during one of the experimental visits. Receives: Other: TP2 |
| Placebo | Placebo comparator | Participants will be administered placebo during one of the experimental visits. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative rehydration
To determine the effect of the test products (TPs) on relative rehydration after exercise, as compared to placebo via percent plasma volume change and plasma osmolality
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (2)
Hydration status via sweat loss
To determine the effect of the TPs on hydration status, as compared to placebo via sweat loss
Measured: Through study completion, an average of 8 weeks
Participants reported outcomes
To determine the effect of the TPs on participant reported outcomes, as compared to placebo via bloating, exertion, exhaustion, thermal sensation, feeling of refreshment, stomach upset, and thirst
Measured: Through study completion, an average of 8 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 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liquid I.V.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis
- Responsible party
- Sponsor
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428228
- Sponsor's protocol ID
- SOW6
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2022
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
- ClinicalTrials.gov ID
- NCT05428228
- Acronym / sponsor ID
- SOW6
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Liquid I.V.University, hospital or other
- Collaborators
- University of Memphis
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- 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.
The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP1 | Experimental | Other: TP1Participants will be administered TP1 during one of the experimental visits. |
| TP2 | Experimental | Other: TP2Participants will be administered TP2 during one of the experimental visits. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be administered placebo during one of the experimental visits. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult male and female participants who are between 18 and 49 years of age (inclusive). Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit. Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive). Exercise regularly as per physical activity guidelines for Americans [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period. Can maintain their exercise status at the beginning of the study throughout the study period. Can achieve a peak VO2 at screening that is at least 60% of their age and gender matched normative value per American College of Sports Medicine recommendations. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to have urine pregnancy test performed on each trial day. Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
Key exclusion criteria (1 listed)
- Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes. Weigh less than or equal to 80 pounds at any visits. Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1). Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than two standard alcoholic drinks per day. Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study. Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. Smoking tobacco products.
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 |
|---|---|---|
| TP1Participants will be administered TP1 during one of the experimental visits. | Other | TP1 |
| TP2Participants will be administered TP2 during one of the experimental visits. | Other | TP2 |
| PlaceboParticipants will be administered placebo during one of the experimental visits. | Other | Placebo |
Primary outcome
Relative rehydration
Time frame: Through study completion, an average of 8 weeks
To determine the effect of the test products (TPs) on relative rehydration after exercise, as compared to placebo via percent plasma volume change and plasma osmolality
2 secondary outcomes
Hydration status via sweat loss
Time frame: Through study completion, an average of 8 weeks
Participants reported outcomes
Time frame: Through study completion, an average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TP1 and TP2 in people with Dehydration and Rehydration, 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Lelko, MS (6787934226, michael.lelko@liquid-iv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative rehydration (time frame: Through study completion, an average of 8 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 29 Jul 2024.