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

NCT07386964 | Not Yet Recruiting

• 1 other identifier: RADX_P_2606_CNM
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function

  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)

  9 weeks

Secondary Outcomes (2)

• Change in cognitive abilities

  9 weeks

• Change in fatigue

  9 weeks

Other Outcomes (3)

• Minimal clinically important difference (MCID) in cognitive function

  9 weeks

• Minimal clinically important difference (MCID) in cognitive abilities

  9 weeks

• Minimal clinically important difference (MCID) in fatigue

  9 weeks

Study Arms (2)

Placebo Clarity Control

PLACEBO COMPARATOR

Clarity Product Placebo Control

Dietary Supplement: Clarity Product Placebo Control

Active Clarity Product

EXPERIMENTAL

Clarity Active Product

Dietary Supplement: Clarity Active Product

Interventions

Clarity Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Clarity Product Placebo Control as directed for a period of 8 weeks

Placebo Clarity Control

Clarity Active Product DIETARY_SUPPLEMENT

Participants will use their Clarity Active Product as directed for a period of 8 weeks

Active Clarity Product

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants must complete all enrollment steps to be stratified. Participants will be stratified based on their sex assignment at birth and health outcome score during enrollment, and e-gamer status, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)