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

Liquid I.V.

Status: Completed

Conditions: Tolerance

Treatments: Other: Placebo; Other: 3 servings of test product; Other: 2 servings of test product; Other: 1 serving of test product

Study type: Interventional

Funder types: Other

Identifiers

NCT05428748

SOW5

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups, including a placebo group

1S

Experimental group

Description:

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

Treatment:

Other: 1 serving of test product

2S

Experimental group

Description:

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

Treatment:

Other: 2 servings of test product

3S

Experimental group

Description:

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

Treatment:

Other: 3 servings of test product

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo