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CompletedNCT07245784Updated May 27, 2026

Radicle Clarity™ RBB: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

An interventional study of Clarity Product Placebo Control and Clarity Active Product 1 in Cognitive Function, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Radicle Science · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
850
Allocation
Randomized
Ages
21 Years to 105 Years
Sex
All
01

Study summary

A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

Read the detailed description

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

Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome and (2) 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 13 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world.

02

Conditions studied

  • Cognitive Function
03

In context

Lead sponsor

Radicle Science is the lead sponsor of 64 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Participants must meet all the following criteria:

  • Adults, at least 21 years of age 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
  • 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 criteria

3.2 Exclusion

Individuals who report any of the following during screening will 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
  • 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.

    • Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
  • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
  • Lack of reliable daily access to the internet
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
850 participants (actual)

Study arms

  • Experimental
    Clarity Active Product 1

    Clarity Active Product 1

    Dietary Supplement: Clarity Active Product 1

  • Placebo comparator
    Clarity Placebo Control

    Clarity Product Placebo Control

    Dietary Supplement: Clarity Product Placebo Control

Interventions

  • Dietary supplementClarity Product Placebo Control

    Participants will use their Clarity Product Control as directed for a period of 12 weeks

  • Dietary supplementClarity Active Product 1

    Participants will use their Clarity Active Product (active ingredient: Himalayan Tartary buckwheat, a high-polyphenol non-grain fruit seed) as directed for a period of 12 weeks.

06

What researchers measure

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: 13 weeks

Secondary outcomes

  1. 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: 13 weeks

  2. Change in sleep-related impairment

    Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)

    Time frame: 13 weeks

  3. 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: 13 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: 13 weeks

  2. 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: 13 weeks

  3. Minimal clinically important difference (MCID) in sleep

    Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)

    Time frame: 13 weeks

  4. 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: 13 weeks

07

Study locations

1 site
  • Radicle Science Inc.
    Del Mar, California 92014, United States
08

References and documents

Related links

Individual participant data

Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07245784
Lead sponsor
Radicle Science
Collaborators
Jeff Bland, Austin Perlmutter
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Dec 4, 2025
Primary completion
May 19, 2026
Completion
May 19, 2026
Last update
May 27, 2026

Study contacts

Susan Hewlings
principal investigator · Radicle Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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