Radicle Clarity CNM™: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes Among E-Gamers

Radicle Science

Status: Begins enrollment this month

Conditions: Cognitive Function

Treatments: Dietary Supplement: Clarity Product Placebo Control; Dietary Supplement: Clarity Active Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT07386964

RADX_P_2606_CNM

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants (1) are aged 21-45, (2) either young professionals or e-gamers, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (4) express acceptance in taking a product and not knowing its formulation until the end of the study.

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 for 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Enrollment: 600 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

600 participants in 2 patient groups, including a placebo group

Placebo Clarity Control

Placebo Comparator group

Description:

Clarity Product Placebo Control

Treatment:

Dietary Supplement: Clarity Product Placebo Control

Active Clarity Product

Experimental group

Description:

Clarity Active Product

Treatment:

Dietary Supplement: Clarity Active Product