Clinical trial NCT06104891: Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy
Fatigue
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 264
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be stratified based on gender at birth, then randomized to one of the study arms
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in energy
timeFrame: 5 hours
Secondary outcomes:
measure: Change in cognitive function
timeFrame: 5 hours
measure: Change in fatigue
timeFrame: 5 hours
measure: Minimal clinically important difference (MCID) in energy
timeFrame: 5 hours
measure: Minimal clinically important difference (MCID) in cognitive function
timeFrame: 5 hours
measure: Minimal clinically important difference (MCID) in fatigue
timeFrame: 5 hours
Other outcomes:
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
affiliation: Radicle Science
name: Emily K. Pauli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: