An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
660
Participants will use their Hydration Active Product 1 as directed for a period of 1 week.
Participants will use their Hydration Active Product 2 as directed for a period of 1 week.
Participants will use their Hydration Active Product 3 as directed for a period of 1 week.
Radicle Science Inc.
Del Mar, California, United States
Hydration: Differences in self-reported perceptions of hydration
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)
Time frame: 2 weeks
Energy: Differences in self-reported perceptions of energy
Energy; Differences in self-reported perceptions of energy as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of energy).
Time frame: 2 weeks
Jitters: Differences in self-reported perceptions of jitters
Jitters; Differences in self-reported perceptions of jitters as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of jitters)
Time frame: 2 weeks
Focus; Differences in self-reported perceptions of focus
Focus; Differences in self-reported perceptions of focus as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of focus)
Time frame: 2 weeks
Productivity: Differences in self-reported perceptions of productivity
Productivity; Differences in self-reported perceptions of productivity as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of productivity)
Time frame: 2 weeks
Confidence: Differences in self-reported perceptions of confidence
Confidence; Differences in self-reported perceptions of confidence as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of confidence).
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Time frame: 2 weeks
Interest in Socializing: Differences in self-reported perceptions of socialization
Interest in Socializing; Differences in self-reported perceptions of socialization as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of socialization)
Time frame: 2 weeks
Feeling Rested: Differences in self-reported perceptions of restfulness
Feeling Rested; Differences in self-reported perceptions of restfulness as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of being rested)
Time frame: 2 weeks
Quality of Sleep: Differences in self-reported perceptions of sleep quality
Quality of Sleep; Differences in self-reported perceptions of sleep quality assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater quality of sleep)
Time frame: 2 weeks