Trials Today

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

Purpose

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

Condition

Cognitive Function

Eligibility

Eligible Ages: Between 21 Years and 105 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion 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 - 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

Exclusion Criteria

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Primary Purpose: Other
Masking: Double (Participant, Investigator)
Masking Description: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Placebo Control 1	Clarity Product Form 1 - control	Dietary Supplement: Placebo Control Form 1 Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Experimental Active Product 1.1	Clarity Product Form 1 - active product 1	Dietary Supplement: Clarity Active Study Product 1.1 Usage Participants will use their Radicle Clarity Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 2	Clarity Product Form 2 - control	Dietary Supplement: Placebo Control Form 2 Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Experimental Active Product 2.1	Clarity Product Form 2 - active product 1	Dietary Supplement: Clarity Active Study Product 2.1 Usage Participants will use their Radicle Clarity Active Study Product 2.1 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 3	Clarity Product Form 3 - control	Dietary Supplement: Placebo Control Form 3 Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Experimental Active Product 3.1	Clarity Product Form 3 - active product 1	Dietary Supplement: Clarity Active Study Product 3.1 Usage Participants will use their Radicle Clarity Active Study Product 3.1 as directed for a period of 6 weeks.
Experimental Active Product 3.2	Clarity Product Form 3 - active product 2	Dietary Supplement: Clarity Active Study Product 3.2 Usage Participants will use their Radicle Clarity Active Study Product 3.2 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 4	Clarity Product Form 4 - control	Dietary Supplement: Placebo Control Form 4 Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Experimental Active Product 4.1	Clarity Product Form 4 - active product 1	Dietary Supplement: Clarity Active Study Product 4.1 Usage Participants will use their Radicle Clarity Active Study Product 4.1 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 5	Clarity Product Form 5 - control	Dietary Supplement: Placebo Control Form 5 Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.
Experimental Active Product 5.1	Clarity Product Form 5 - active product 1	Dietary Supplement: Clarity Active Study Product 5.1 Usage Participants will use their Radicle Clarity Active Study Product 5.1 as directed for a period of 6 weeks.
Experimental Active Product 5.2	Clarity Product Form 5 - active product 2	Dietary Supplement: Clarity Active Study Product 5.2 Usage Participants will use their Radicle Clarity Active Study Product 5.2 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 6	Clarity Product Form 6 - control	Dietary Supplement: Placebo Control Form 6 Participants will use their Placebo Control Form 6 as directed for a period of 6 weeks. Dietary Supplement: Placebo Control 6.1.0 Participants will use their Placebo Control 6.1.0 as directed for a period of 6 weeks.
Experimental Active Product 6.1	Clarity Product Form 6 - active product 1	Dietary Supplement: Clarity Active Study Product 6.1 Usage Participants will use their Radicle Clarity Active Study Product 6.1 as directed for a period of 6 weeks. Dietary Supplement: Clarity Active Study Product 6.1.1 Usage Participants will use their Radicle Clarity Active Study Product 6.1.1 as directed for a period of 6 weeks.
Placebo Comparator Placebo Control 6.1.0	Clarity Product 6.1.0 - control	Dietary Supplement: Placebo Control 6.1.0 Participants will use their Placebo Control 6.1.0 as directed for a period of 6 weeks.
Experimental Active Product 6.1.1	Clarity Product 6.1.1 - active product 1	Dietary Supplement: Clarity Active Study Product 6.1.1 Usage Participants will use their Radicle Clarity Active Study Product 6.1.1 as directed for a period of 6 weeks.
Experimental Active product 6.1.2	Clarity Product 6.1.2	Dietary Supplement: Clarity Active Study Product 6.1.2 Usage Participants will use their Radicle Clarity Active Study Product 6.1.2 as directed for a period of 6 weeks.

Recruiting Locations

Radicle Science, Inc
Del Mar, California 92014

Contact:
Study Management
760-281-3898
studymgmt@radiclescience.com

More Details

NCT ID: NCT06294431
Status: Recruiting
Sponsor: Radicle Science

Study Contact

Study Manager
760-281-3898
studymgmt@radiclescience.com

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for better concentration, (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) 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 7 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 evidence study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.