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

Not Applicable

Completed

• Conditions: Energy; Fatigue
• Interventions: Dietary Supplement: Recharge Placebo Control 1; Dietary Supplement: Recharge Active Study Product 3; Dietary Supplement: Recharge Active Study Product 2; Dietary Supplement: Recharge Active Study Product 1

• Registration Number: NCT06104891
• Lead Sponsor: Radicle Science

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study Start: 2023-10-25
• Primary Completion: 2023-10-26
• Study First Posted: 2023-10-27
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control 1	Recharge Placebo Control 1	Recharge Product Form 1 - control
Active Product 3	Recharge Active Study Product 3	Recharge Product Form 4 - active product 1
Active Product 2	Recharge Active Study Product 2	Recharge Product Form 3 - active product 1
Active Product 1	Recharge Active Study Product 1	Recharge Product Form 2 - active product 1

Primary Outcome Measures

Name	Time	Method
Change in energy	5 hours	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)

Secondary Outcome Measures

Name	Time	Method
Change in fatigue	5 hours	Mean difference in fatigue score as assessed by Fatigue VAS (scale 0 - 10; where 0 is no fatigue and 10 is completely exhausted)
Minimal clinically important difference (MCID) in fatigue	5 hours	Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS
Change in cognitive function	5 hours	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"
Minimal clinically important difference (MCID) in energy	5 hours	Likelihood of experiencing MCID in energy score as assessed by Energy VAS
Minimal clinically important difference (MCID) in cognitive function	5 hours	Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A

Trial Locations

Locations (1)

Radicle Science, Inc; 🇺🇸 Del Mar, California, United States