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Completed

NCT Number: NCT05428748

Clinical Trial to Evaluate 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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Memphis

Memphis, Tennessee, 38152, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 serving of test product

Other

Participants will consume 1 serving/day of the test product for 28 days

2 servings of test product

Other

Participants will consume 2 servings/day of the test product for 28 days

3 servings of test product

Other

Participants will consume 3 servings/day of the test product for 28 days

Placebo

Other

Participants will consume 1 serving/day of the placebo for 28 days

Primary outcomes

  1. Safety of test product

    Time frame: 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.

  2. Tolerability of test product

    Time frame: 28 days

    To assess the tolerability of the test product via participant tolerability questionnaire.

Sponsors and collaborators

Lead sponsor

Liquid I.V.

Other

Collaborators

  • University of Memphis

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2022
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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