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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05428748
Other study ID # SOW5
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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