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A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes
This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Energy Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Energy Product Form 1 - active product 1 |
|
| Active Product 1.2 | Experimental | Energy Product Form 1 - active product 2 |
|
| Active Product 1.3 | Experimental | Energy Product Form 1 - active product 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Placebo Control Form 1 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue | Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in focus (cognitive function) | Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function) | 6 weeks |
| Change in sleep |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mood (emotional distress-depression) | Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| Change in libido |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science Inc. | 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' study product assignment. Participants are blinded to the study product they are assigned.
| Energy Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Energy Active Study Product 1.2 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks. |
|
| Energy Active Study Product 1.3 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks. |
|
Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)
| 6 weeks |
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety) | 6 weeks |
| Minimal clinically important difference (MCID) in fatigue | Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A | 6 weeks |
| Minimal clinically important difference (MCID) in focus (cognitive function) | Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A | 6 weeks |
| Minimal clinically important difference (MCID) in sleep | Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A | 6 weeks |
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity) |
| 6 weeks |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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