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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06104891
• Other study ID #: RADX-2317
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: April 30, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy
• Fatigue

Intervention

Dietary Supplement:
• Recharge Placebo Control 1
Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.
• Recharge Active Study Product 1
Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.
• Recharge Active Study Product 2
Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.
• Recharge Active Study Product 3
Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Minimal clinically important difference (MCID) in energy	Likelihood of experiencing MCID in energy score as assessed by Energy VAS	5 hours
Secondary	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
Secondary	Minimal clinically important difference (MCID) in fatigue	Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS	5 hours

External Links

•   Radicle Science, Inc