ClinicalTrials.gg
Status unknownNCT05428228Updated Jul 29, 2024

Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

An interventional study of TP1 and TP2 in Dehydration, Rehydration and Exercise Performance, sponsored by Liquid I.V.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Liquid I.V. · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study summary

The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.

02

Conditions studied

  • Dehydration
  • Rehydration
  • Exercise Performance
  • Exercise Recovery
  • Cognitive Performance

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03

In context

Dehydration

208 studies on the registry are indexed under Dehydration; 29 are open to participants now.

This study's planned enrollment of 16 is below the median of 42 across 150 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

Liquid I.V. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    TP1

    Participants will be administered TP1 during one of the experimental visits.

    Other: TP1

  • Experimental
    TP2

    Participants will be administered TP2 during one of the experimental visits.

    Other: TP2

  • Placebo comparator
    Placebo

    Participants will be administered placebo during one of the experimental visits.

    Other: Placebo

Interventions

  • OtherTP1

    Participants will be administered TP1 during one of the experimental visits.

  • OtherTP2

    Participants will be administered TP2 during one of the experimental visits.

  • OtherPlacebo

    Participants will be administered placebo during one of the experimental visits.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, an average of 8 weeks

Secondary outcomes

  1. Hydration status via sweat loss

    To determine the effect of the TPs on hydration status, as compared to placebo via sweat loss

    Time frame: Through study completion, an average of 8 weeks

  2. 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

    Time frame: Through study completion, an average of 8 weeks

Other outcomes

  1. Relative effects of dehydration and rehydration

    To explore the relative effects of dehydration and rehydration from the TPs and control on cognitive function, as compared to placebo via NIH cognitive toolbox - Flanker inhibitory control and attention testing performance

    Time frame: Through study completion, an average of 8 weeks

  2. Exercise performance

    To explore the effect of the TPs on exercise performance, as compared to placebo via time to exhaustion

    Time frame: Through study completion, an average of 8 weeks

07

Study locations

1 of 1 sites recruiting
  • The University of Memphis
    Memphis, Tennessee 38152, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05428228
Lead sponsor
Liquid I.V.
Collaborators
University of Memphis
Responsible party
Sponsor
First posted
Jun 23, 2022
Start date
Oct 1, 2022
Primary completion
Sep 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Jul 29, 2024

Study contacts

Michael Lelko, MS
Contact
michael.lelko@liquid-iv.com
6787934226
Richard Bloomer, PhD
principal investigator · University of Memphis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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