Last updated: July 26, 2024
Sponsor: Liquid I.V.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Low Blood Pressure (Hypotension)
Brain Function
Treatment
Placebo
TP1
TP2
Clinical Study ID
NCT05428228
SOW6
Ages 18-35 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 orconditions) and can ingest the assigned amount of fluid at each visit. Have a bodymass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive). Exercise regularly as perphysical activity guidelines for Americans [structured exercise for a minimum of 150cumulative 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 throughoutthe study period. Can maintain their exercise status at the beginning of the studythroughout 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 SportsMedicine recommendations. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to haveurine pregnancy test performed on each trial day. Able to agree to the requirementsand restrictions of this study, willing to give voluntary consent, able tounderstand and read the questionnaires, and carry out all study-related procedures.
Exclusion
Exclusion Criteria:
- Female participants who are lactating, pregnant or planning to become pregnantduring the study. Carry a diagnosis of diabetes. Weigh less than or equal to 80pounds at any visits. Answer "yes" to any of the questions asked on the screeningquestionnaire (Appendix 10.2.1). Have a history of a diagnosis of celiac disease,chronic pancreatitis, steatorrhea, unstable thyroid disease, major affectivedisorder, psychiatric disorder that required hospitalization in the prior year,immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer withoutmetastases or in situ cervical cancer within 5 years prior to screening visit). Useany dietary supplements that may impact hydration status within the 30 days prior tothe baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than twostandard 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 firstdose of the study product or for the duration of the study. Have a medical conditionthat may impact ability to exercise or ability to ingest prescribed fluid volume.Smoking tobacco products.
Study Design
Total Participants: 16
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
September 01, 2024
Connect with a study center
The University of Memphis
Memphis, Tennessee 38152
United StatesActive - Recruiting
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