Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
An Open-label, Parallel and Randomized Trial to Assess the Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
1 other identifier
interventional
40
1 country
1
Brief Summary
This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJuly 29, 2024
July 1, 2024
5 months
June 15, 2022
July 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Safety of test product
To assess the safety of the test product (TP) via comprehensive metabolic panel, complete blood count, urinalysis, vitals, and observed or reported adverse events.
28 days
Tolerability of test product
To assess the tolerability of the test product via participant tolerability questionnaire.
28 days
Study Arms (4)
1S
EXPERIMENTALParticipants will consume 1 serving/day of the test product for 28 days.
2S
EXPERIMENTALParticipants will consume 2 servings/day of the test product for 28 days
3S
EXPERIMENTALParticipants will consume 3 servings/day of the test product for 28 days
Placebo
PLACEBO COMPARATORParticipants will consume 1 serving/day of the placebo for 28 days
Interventions
Participants will consume 1 serving/day of the test product for 28 days
Participants will consume 2 servings/day of the test product for 28 days
Participants will consume 3 servings/day of the test product for 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liquid I.V.lead
- University of Memphiscollaborator
Study Sites (1)
The University of Memphis
Memphis, Tennessee, 38152, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bloomer, PhD
University of Memphis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2022
First Posted
June 23, 2022
Study Start
September 1, 2022
Primary Completion
February 1, 2023
Study Completion
March 1, 2023
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share