Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers

Not Applicable

Completed

• Conditions: Tolerance
• Interventions: Other: 2 servings of test product; Other: 1 serving of test product; Other: 3 servings of test product; Other: Placebo

• Registration Number: NCT05428748
• Lead Sponsor: Liquid I.V.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-09-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2S	2 servings of test product	Participants will consume 2 servings/day of the test product for 28 days
1S	1 serving of test product	Participants will consume 1 serving/day of the test product for 28 days.
3S	3 servings of test product	Participants will consume 3 servings/day of the test product for 28 days
Placebo	Placebo	Participants will consume 1 serving/day of the placebo for 28 days

Primary Outcome Measures

Name	Time	Method
Safety of test product	28 days	To assess the safety of the test product (TP) via comprehensive metabolic panel, complete blood count, urinalysis, vitals, and observed or reported adverse events.
Tolerability of test product	28 days	To assess the tolerability of the test product via participant tolerability questionnaire.

Trial Locations

Locations (1)

The University of Memphis; 🇺🇸 Memphis, Tennessee, United States