search
Back to results

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

Primary Purpose

Dehydration, Rehydration, Exercise Performance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TP1
TP2
Placebo
Sponsored by
Liquid I.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    TP1

    TP2

    Placebo

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 15, 2022
    Last Updated
    June 17, 2022
    Sponsor
    Liquid I.V.
    Collaborators
    University of Memphis
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05428228
    Brief Title
    Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Liquid I.V.
    Collaborators
    University of Memphis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dehydration, Rehydration, Exercise Performance, Exercise Recovery, Cognitive Performance

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TP1
    Arm Type
    Experimental
    Arm Description
    Participants will be administered TP1 during one of the experimental visits.
    Arm Title
    TP2
    Arm Type
    Experimental
    Arm Description
    Participants will be administered TP2 during one of the experimental visits.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be administered placebo during one of the experimental visits.
    Intervention Type
    Other
    Intervention Name(s)
    TP1
    Intervention Description
    Participants will be administered TP1 during one of the experimental visits.
    Intervention Type
    Other
    Intervention Name(s)
    TP2
    Intervention Description
    Participants will be administered TP2 during one of the experimental visits.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants will be administered placebo during one of the experimental visits.
    Primary Outcome Measure Information:
    Title
    Relative rehydration
    Description
    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 Outcome Measure Information:
    Title
    Hydration status via sweat loss
    Description
    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
    Title
    Participants reported outcomes
    Description
    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 Pre-specified Outcome Measures:
    Title
    Relative effects of dehydration and rehydration
    Description
    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
    Title
    Exercise performance
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Lelko, MS
    Phone
    6787934226
    Email
    michael.lelko@liquid-iv.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Bloomer, PhD
    Organizational Affiliation
    University of Memphis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs