Status:
COMPLETED
Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
Lead Sponsor:
Liquid I.V.
Collaborating Sponsors:
University of Memphis
Conditions:
Tolerance
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.
Eligibility Criteria
Inclusion
- Healthy individuals who are between 18 - 35 years of age. Have a body mass index (BMI) range of 18.0 - 24.9 kg/m2. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Exclusion
- Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes. Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). Individuals who are lactating, pregnant or planning to become pregnant during the study. Have a known sensitivity or allergy to any of the study products. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. History of alcohol or substance abuse in the 12 months prior to screening. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05428748
Start Date
September 1 2022
End Date
March 1 2023
Last Update
July 29 2024
Active Locations (1)
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1
The University of Memphis
Memphis, Tennessee, United States, 38152