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

NCT07245784 | Recruiting

• 1 other identifier: RADX_P_2406_RBB
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

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

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)

  13 weeks

Secondary Outcomes (3)

• Change in fatigue

  13 weeks

• Change in sleep-related impairment

  13 weeks

• Change in cognitive abilities

  13 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in cognitive function

  13 weeks

• Minimal clinically important difference (MCID) in fatigue

  13 weeks

• Minimal clinically important difference (MCID) in sleep

  13 weeks

Study Arms (2)

Clarity Active Product 1

EXPERIMENTAL

Clarity Active Product 1

Dietary Supplement: Clarity Active Product 1

Clarity Placebo Control

PLACEBO COMPARATOR

Clarity Product Placebo Control

Dietary Supplement: Clarity Product Placebo Control

Interventions

Clarity Product Placebo Control DIETARY_SUPPLEMENT

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

Clarity Placebo Control

Clarity Active Product 1 DIETARY_SUPPLEMENT

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.

Clarity Active Product 1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Radicle Science: lead
• Jeff Bland: collaborator
• Austin Perlmutter: collaborator

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

RECRUITING

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 completing baseline will be stratified based on their sex assignment at birth, health outcome score, and age during enrollment, 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 the study insert with instructions for use and study participation.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)