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

Completed · Not applicable · Has a placebo group

Conditions studied: Tolerance

In brief

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

Key facts

Study ID

NCT05428748

Run by

Liquid I.V.

People needed

40

Starts

2022-09-01

Expected to finish

2023-03-01

Last updated by the study team

2024-07-29

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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