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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Recharge Product Form 1 - control |
|
| Active Product 1 | Experimental | Recharge Product Form 2 - active product 1 |
|
| Active Product 2 | Experimental | Recharge Product Form 3 - active product 1 |
|
| Active Product 3 | Experimental | Recharge Product Form 4 - active product 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recharge Placebo Control 1 | Dietary Supplement | Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Participants will be stratified based on gender at birth, then randomized to one of the study arms
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The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
| Recharge Active Study Product 1 | Dietary Supplement | Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours. |
|
| Recharge Active Study Product 2 | Dietary Supplement | Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours. |
|
| Recharge Active Study Product 3 | Dietary Supplement | Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 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 |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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