Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes

Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes

A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes

Study Overview

• Status: Completed
• Conditions: Fatigue; Energy
• Intervention / Treatment: Dietary supplement: Recharge Placebo Control 1; Dietary supplement: Recharge Active Study Product 1; Dietary supplement: Recharge Active Study Product 2; Dietary supplement: Recharge Active Study Product 3

Detailed Description

This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.

Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.

Participants will take their assigned study product at a Radicle booth, after enrolling.

Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.

• Study Type: Interventional
• Enrollment (Actual): 264
• 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 at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
• Attending the Supply Side West meeting in person
• Able to read and understand English
• Endorses more energy as a primary desire
• 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
• Reports current enrollment in another clinical trial
• Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
• Reports an allergy to any of the study products ingredients

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; Recharge Product Form 1 - control	Dietary supplement: Recharge Placebo Control 1; Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.
Experimental: Active Product 1; Recharge Product Form 2 - active product 1	Dietary supplement: Recharge Active Study Product 1; Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.
Experimental: Active Product 2; Recharge Product Form 3 - active product 1	Dietary supplement: Recharge Active Study Product 2; Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.
Experimental: Active Product 3; Recharge Product Form 4 - active product 1	Dietary supplement: Recharge Active Study Product 3; Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in energy	Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy)	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function	Mean difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function - Abilities 4A (scale 4-20; where lower scores correspond to worse cognitive function). Modified timing to, "since walking this morning"	5 hours
Change in fatigue	Mean difference in fatigue score as assessed by Fatigue VAS (scale 0 - 10; where 0 is no fatigue and 10 is completely exhausted)	5 hours
Minimal clinically important difference (MCID) in energy	Likelihood of experiencing MCID in energy score as assessed by Energy VAS	5 hours
Minimal clinically important difference (MCID) in cognitive function	Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A	5 hours
Minimal clinically important difference (MCID) in fatigue	Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS	5 hours

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

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

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: RADX-2317

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