Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

Study Overview

• Status: Completed
• Conditions: Fatigue; Energy
• Intervention / Treatment: Dietary supplement: Energy Placebo Control Form 1; Dietary supplement: Energy Active Study Product 1.1 Usage; Dietary supplement: Energy Active Study Product 1.2 Usage; Dietary supplement: Energy Active Study Product 1.3 Usage

Detailed Description

This is a parallel group, randomized, double-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 more energy, (2) have the opportunity for meaningful improvement in their health outcome score, 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 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.

• Study Type: Interventional
• Enrollment (Actual): 1189
• 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: 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, 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 more energy as a primary desire
• Has the opportunity for at least 20% improvement in their primary health outcome score
• 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
• 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 another clinical trial
• Lack of reliable daily access to the internet
• Reports current use of chemotherapy or immunotherapy
• Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Energy Product Form 1 - control	Dietary supplement: Energy Placebo Control Form 1; Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.
Experimental: Active Product 1.1; Energy Product Form 1 - active product 1	Dietary supplement: Energy Active Study Product 1.1 Usage; Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.
Experimental: Active Product 1.2; Energy Product Form 1 - active product 2	Dietary supplement: Energy Active Study Product 1.2 Usage; Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.
Experimental: Active Product 1.3; Energy Product Form 1 - active product 3	Dietary supplement: Energy Active Study Product 1.3 Usage; Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue	Mean difference 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)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in focus (cognitive function)	Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)	6 weeks
Change in sleep	Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)	6 weeks
Change in feelings of anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety)	6 weeks
Minimal clinically important difference (MCID) in fatigue	Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A	6 weeks
Minimal clinically important difference (MCID) in focus (cognitive function)	Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A	6 weeks
Minimal clinically important difference (MCID) in sleep	Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A	6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood (emotional distress-depression)	Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)	6 weeks
Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)	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): September 26, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: RADX-2304

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