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

Tolerance Clinical Trial

Official title:

An Open-label, Parallel and Randomized Trial to Assess the Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05428748
• Other study ID #: SOW5
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2022
• Source: Liquid I.V.
• Contact: Michael Lelko, MS
• Phone: 6787934226
• Email: michael.lelko[@]liquid-iv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Tolerance

Intervention

Other:
• 1 serving of test product
Participants will consume 1 serving/day of the test product for 28 days
• 2 servings of test product
Participants will consume 2 servings/day of the test product for 28 days
• 3 servings of test product
Participants will consume 3 servings/day of the test product for 28 days
• Placebo
Participants will consume 1 serving/day of the placebo for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Liquid I.V.	University of Memphis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tolerability of test product	To assess the tolerability of the test product via participant tolerability questionnaire.	28 days