Active, not recruiting
Not applicable
Radicle Clarity CNM™: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes Among E-Gamers
Condition(s) studied
Cognitive Function
Investigational drug(s) / intervention(s)
Clarity Product Placebo ControlClarity Active Product
Clarity Product Placebo Control: Participants will use their Clarity Product Placebo Control as directed for a period of 8 weeks
Clarity Active Product: Participants will use their Clarity Active Product as directed for a period of 8 weeks
Study summary
Radicle Clarity CNM™: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on cognitive function and related health outcomes among E-Gamers.
Eligibility
Inclusion
Participants must meet all the following criteria:
* Adults, aged 21 - 45 years at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
* Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
* Identifies as a young professional (working 30+ hrs/week)
* May identify as an E-gamer (playing video games 5+hrs/week for the past year)
* Resides in the United States
* Has the opportunity for at least 30% improvement in their primary health outcome
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Exclusion
Individuals who report any of the following during screening may 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
* Reports current enrollment in another clinical trial
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English at a 7th grade level
* 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.
Primary outcome measure(s)
- Change in cognitive function — 9 weeks
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
Trial sites (1)
| Facility | City | Region | Status |
| Radicle Science Inc. |
Del Mar |
California |
|
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