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

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

Detailed Description
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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.

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

Conditions
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Energy, Fatigue

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified based on gender at birth, then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1<br>Recharge Product Form 1 - control | Dietary Supplement: Recharge Placebo Control 1<br>* Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.<br>|
| Experimental: Active Product 1<br>Recharge Product Form 2 - active product 1 | Dietary Supplement: Recharge Active Study Product 1<br>* Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.<br>|
| Experimental: Active Product 2<br>Recharge Product Form 3 - active product 1 | Dietary Supplement: Recharge Active Study Product 2<br>* Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.<br>|
| Experimental: Active Product 3<br>Recharge Product Form 4 - active product 1 | Dietary Supplement: Recharge Active Study Product 3<br>* Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.<br>|

What is the study measuring?
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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 |