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

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

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

Conditions
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Tolerance

Intervention / Treatment
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* Other: 1 serving of test product
* Other: 2 servings of test product
* Other: 3 servings of test product
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1S<br>Participants will consume 1 serving/day of the test product for 28 days. | Other: 1 serving of test product<br>* Participants will consume 1 serving/day of the test product for 28 days<br>|
| Experimental: 2S<br>Participants will consume 2 servings/day of the test product for 28 days | Other: 2 servings of test product<br>* Participants will consume 2 servings/day of the test product for 28 days<br>|
| Experimental: 3S<br>Participants will consume 3 servings/day of the test product for 28 days | Other: 3 servings of test product<br>* Participants will consume 3 servings/day of the test product for 28 days<br>|
| Placebo Comparator: Placebo<br>Participants will consume 1 serving/day of the placebo for 28 days | Other: Placebo<br>* Participants will consume 1 serving/day of the placebo for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Tolerability of test product | To assess the tolerability of the test product via participant tolerability questionnaire. | 28 days |