An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydration Active Product 1, Hydration Active Product 2, Hydration Active Product 3.
- Who it may be relevant to
- Registry conditions: Hydration. Basic parameters: 21 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
Detailed description
This is an open label study conducted with adult participants residing in the United States.
Eligible participants will (1) agree to consume a hydration product, (2) agree not to take any other hydration or electrolyte supplements for the duration of the trial, (3) be 21 years of age or older, and (4) agree to participate in this study for 2 week and answer assessments.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants over 2 weeks. Participant reports of health indicators will be collected at screening and throughout the active period of study product use. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Interventions
- Dietary supplement Hydration Active Product 1
Participants will use their Hydration Active Product 1 as directed for a period of 1 week. - Dietary supplement Hydration Active Product 2
Participants will use their Hydration Active Product 2 as directed for a period of 1 week. - Dietary supplement Hydration Active Product 3
Participants will use their Hydration Active Product 3 as directed for a period of 1 week.
Primary outcome measures
- Hydration: Differences in self-reported perceptions of hydration [Time frame: 2 weeks]
Secondary outcome measures (8)
- Energy: Differences in self-reported perceptions of energy [Time frame: 2 weeks]
- Jitters: Differences in self-reported perceptions of jitters [Time frame: 2 weeks]
- Focus; Differences in self-reported perceptions of focus [Time frame: 2 weeks]
- Productivity: Differences in self-reported perceptions of productivity [Time frame: 2 weeks]
- Confidence: Differences in self-reported perceptions of confidence [Time frame: 2 weeks]
- Interest in Socializing: Differences in self-reported perceptions of socialization [Time frame: 2 weeks]
- Feeling Rested: Differences in self-reported perceptions of restfulness [Time frame: 2 weeks]
- Quality of Sleep: Differences in self-reported perceptions of sleep quality [Time frame: 2 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Radicle Science Inc. — Del Mar
Identifiers
NCT: NCT07206979 · RADX_OL_2505_LIV