Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes

NCT06294431 | Completed

• 1 other identifier: RADX-P-2406
• Study Type: interventional
• Target: 4,794
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function

  Mean difference in cognition function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function Short Form 8A (scale 8-40; where the higher scores correspond to greater cognitive function)

  6 weeks

Secondary Outcomes (3)

• Change in fatigue

  6 weeks

• Change in sleep-related impairment

  6 weeks

• Minimal clinical importance difference (MCID) in cognitive function

  6 weeks

Other Outcomes (2)

• Change in mood (emotional distress-depression)

  6 weeks

• Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

  6 weeks

Study Arms (17)

Placebo Control 1

PLACEBO COMPARATOR

Clarity Product Form 1 - control

Dietary Supplement: Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Clarity Product Form 1 - active product 1

Dietary Supplement: Clarity Active Study Product 1.1 Usage

Placebo Control 2

PLACEBO COMPARATOR

Clarity Product Form 2 - control

Dietary Supplement: Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

Clarity Product Form 2 - active product 1

Dietary Supplement: Clarity Active Study Product 2.1 Usage

Placebo Control 3

PLACEBO COMPARATOR

Clarity Product Form 3 - control

Dietary Supplement: Placebo Control Form 3

Active Product 3.1

EXPERIMENTAL

Clarity Product Form 3 - active product 1

Dietary Supplement: Clarity Active Study Product 3.1 Usage

Active Product 3.2

EXPERIMENTAL

Clarity Product Form 3 - active product 2

Dietary Supplement: Clarity Active Study Product 3.2 Usage

Placebo Control 4

PLACEBO COMPARATOR

Clarity Product Form 4 - control

Dietary Supplement: Placebo Control Form 4

Active Product 4.1

EXPERIMENTAL

Clarity Product Form 4 - active product 1

Dietary Supplement: Clarity Active Study Product 4.1 Usage

Placebo Control 5

PLACEBO COMPARATOR

Clarity Product Form 5 - control

Dietary Supplement: Placebo Control Form 5

Active Product 5.1

EXPERIMENTAL

Clarity Product Form 5 - active product 1

Dietary Supplement: Clarity Active Study Product 5.1 Usage

Active Product 5.2

EXPERIMENTAL

Clarity Product Form 5 - active product 2

Dietary Supplement: Clarity Active Study Product 5.2 Usage

Placebo Control 6

PLACEBO COMPARATOR

Clarity Product Form 6 - control

Dietary Supplement: Placebo Control Form 6

Active Product 6.1

EXPERIMENTAL

Clarity Product Form 6 - active product 1

Dietary Supplement: Clarity Active Study Product 6.1 Usage

Placebo Control 6.1.0

PLACEBO COMPARATOR

Clarity Product 6.1.0 - control

Dietary Supplement: Placebo Control 6.1.0

Active Product 6.1.1

EXPERIMENTAL

Clarity Product 6.1.1 - active product 1

Dietary Supplement: Clarity Active Study Product 6.1.1 Usage

Active product 6.1.2

EXPERIMENTAL

Clarity Product 6.1.2

Dietary Supplement: Clarity Active Study Product 6.1.2 Usage

Interventions

Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Clarity Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Placebo Control Form 2 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2

Clarity Active Study Product 2.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1

Placebo Control Form 3 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.

Placebo Control 3

Clarity Active Study Product 3.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 3.1 as directed for a period of 6 weeks.

Active Product 3.1

Clarity Active Study Product 3.2 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 3.2 as directed for a period of 6 weeks.

Active Product 3.2

Placebo Control Form 4 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.

Placebo Control 4

Clarity Active Study Product 4.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 4.1 as directed for a period of 6 weeks.

Active Product 4.1

Placebo Control Form 5 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.

Placebo Control 5

Clarity Active Study Product 5.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 5.1 as directed for a period of 6 weeks.

Active Product 5.1

Clarity Active Study Product 5.2 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 5.2 as directed for a period of 6 weeks.

Active Product 5.2

Placebo Control Form 6 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 6 as directed for a period of 6 weeks.

Placebo Control 6

Clarity Active Study Product 6.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 6.1 as directed for a period of 6 weeks.

Active Product 6.1

Placebo Control 6.1.0 DIETARY_SUPPLEMENT

Participants will use their Placebo Control 6.1.0 as directed for a period of 6 weeks.

Placebo Control 6.1.0

Clarity Active Study Product 6.1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 6.1.1 as directed for a period of 6 weeks.

Active Product 6.1.1

Clarity Active Study Product 6.1.2 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Clarity Active Study Product 6.1.2 as directed for a period of 6 weeks.

Active product 6.1.2

Eligibility Criteria

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

You may qualify if:

• 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
• Endorses better concentration or cognitive function (fewer feelings of brain fog) as a primary desire
• Has the opportunity for at least 20% 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:

• 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 lak
• Reports a diagnosis or 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 (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

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: Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 5, 2024
• Study Start: March 4, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)