Radicle Science, Inc
Del Mar, California, 92014, United States
NCT Number: NCT06104891
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes
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Notify Me21 year–105 year
All sexes
Interventional
Not applicable
Del Mar, California, 92014, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.
Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.
Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.
Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.
Time frame: 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)
Time frame: 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"
Time frame: 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)
Time frame: 5 hours
Likelihood of experiencing MCID in energy score as assessed by Energy VAS
Time frame: 5 hours
Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A
Time frame: 5 hours
Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS
Radicle Science
Industry
Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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