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

This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.

Study Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Other: 1 serving of test product; Other: 2 servings of test product; Other: 3 servings of test product; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • The University of Memphis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1S; Participants will consume 1 serving/day of the test product for 28 days.	Other: 1 serving of test product; Participants will consume 1 serving/day of the test product for 28 days
Experimental: 2S; Participants will consume 2 servings/day of the test product for 28 days	Other: 2 servings of test product; Participants will consume 2 servings/day of the test product for 28 days
Experimental: 3S; Participants will consume 3 servings/day of the test product for 28 days	Other: 3 servings of test product; Participants will consume 3 servings/day of the test product for 28 days
Placebo Comparator: Placebo; Participants will consume 1 serving/day of the placebo for 28 days	Other: Placebo; Participants will consume 1 serving/day of the placebo for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Liquid I.V.
• Collaborators: University of Memphis
• Investigators: Principal Investigator: Richard Bloomer, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SOW5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No