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
About this trial
This is an interventional basic science trial for Dehydration
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.
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
NCT ID
NCT05428228
First Posted
June 15, 2022
Last Updated
June 17, 2022
Sponsor
Liquid I.V.
Collaborators
University of Memphis
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
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Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
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