Radicle Clarity: A Study of Health and Wellness Products on Mental Clarity and Health Outcomes

Radicle™ Clarity: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Cognitive Function and Other Health Outcomes

A randomized, blinded, placebo-controlled direct-to-consumer study of health and wellness products on mental clarity and other health outcomes

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Placebo Control Form 1; Dietary supplement: Placebo Control Form 2; Dietary supplement: Placebo Control Form 3; Dietary supplement: Placebo Control Form 4; Dietary supplement: Clarity Active Study Product 1.1 Usage; Dietary supplement: Clarity Active Study Product 2.1 Usage; Dietary supplement: Clarity Active Study Product 3.1 Usage; Dietary supplement: Clarity Active Study Product 4.1 Usage; Dietary supplement: Clarity Active Study Product 4.2 Usage; Dietary supplement: Clarity Active Study Product 4.3 Usage; Dietary supplement: Placebo Control Form 5; Dietary supplement: Clarity Active Study Product 5.1 Usage; Dietary supplement: Clarity Active Study Product 5.2 Usage

Detailed Description

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better concentration, (2) indicate an interest in taking a health and wellness product to potentially help their concentration, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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.

• Study Type: Interventional
• Enrollment (Actual): 4826
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses better concentration as a primary desire
• Selects concentration and/or looking to improve their concentration as a reason for their interest in taking a health and wellness product
• 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:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• The calculated validated health survey (PRO) score during enrollment represents less than mild impairment or severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAOIs (monoamine oxidase inhibitors)
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.
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.
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 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.
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.
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 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.
Experimental: Active Product 4.2; Clarity Product Form 4 - active product 2	Dietary supplement: Clarity Active Study Product 4.2 Usage; Participants will use their Radicle Clarity Active Study Product 4.2 as directed for a period of 6 weeks.
Experimental: Active Product 4.3; Clarity Product Form 4 - active product 3	Dietary supplement: Clarity Active Study Product 4.3 Usage; Participants will use their Radicle Clarity Active Study Product 4.3 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognition (mental clarity)	Mean difference in cognition 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in executive functioning	Mean difference in cognition score as assessed by Adult Executive Functioning Inventory (ADEXI) (scale 1-5; with higher scores corresponding to lower executive functioning)	6 weeks
Change in sleep quality	Mean difference in sleep quality score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to greater sleep disturbance)	6 weeks
Change in energy (fatigue)	Mean difference in energy score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)	6 weeks
Change in anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Change in mood (emotional distress)	Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression)	6 weeks
Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest)	6 weeks
Minimal clinical importance difference (MCID) in cognitive function	Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function Short Form 8A (scale 8-40; where the higher scores correspond to greater cognitive function)	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RADX-2306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No