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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorRadicle Science

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clarity Product Placebo Control

    Dietary supplement

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

  • Clarity Active Product

    Dietary supplement

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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Placebo Clarity ControlPlacebo comparator 1 intervention
Group B: Active Clarity ProductExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
9 weeks

Secondary outcomes

1

Change in cognitive abilities

Change in cognitive abilities: Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)

Time frame
9 weeks
2

Change in fatigue

Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

Time frame
9 weeks

Other outcomes

1

Minimal clinically important difference (MCID) in cognitive function

Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)

Time frame
9 weeks
2

Minimal clinically important difference (MCID) in cognitive abilities

Minimal clinically important difference (MCID) in cognitive abilities: Likelihood of experiencing minimal clinically important difference in cognitive abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)

Time frame
9 weeks
3

Minimal clinically important difference (MCID) in fatigue

Minimal clinically important difference (MCID) in fatigue: Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

Time frame
9 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: