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An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
Condition(s) studied
Hydration
Investigational drug(s) / intervention(s)
Hydration Active Product 1Hydration Active Product 2Hydration Active Product 3
Hydration Active Product 1: Participants will use their Hydration Active Product 1 as directed for a period of 1 week.
Hydration Active Product 2: Participants will use their Hydration Active Product 2 as directed for a period of 1 week.
Hydration Active Product 3: Participants will use their Hydration Active Product 3 as directed for a period of 1 week.
Study summary
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
Eligibility
3.1 Inclusion
Participants must meet all the following criteria:
* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races.
* Resides in the United States.
3.2 Exclusion
Individuals who report any of the following during screening will be excluded from participation:
* Report being pregnant, trying to become pregnant, or breastfeeding.
* Unable to provide a valid US shipping address and mobile phone number
* Unable to read and understand English.
* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
* NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure.
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
* Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products.
* Reports the current use of electrolyte and/or hydration supplements that may limit the effects of the study products.
* Lack of reliable daily access to the internet.
Primary outcome measure(s)
- Hydration: Differences in self-reported perceptions of hydration — 2 weeks
Hydration; Differences in self-reported perceptions of hydration as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of hydration)
Trial sites (1)
| Facility | City | Region | Status |
| Radicle Science Inc. |
Del Mar |
California |
|
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