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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) endorse a desire for more energy/less fatigue, (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 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 |
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| Placebo Control 2 | Placebo Comparator | Energy Product Form 2 - control |
|
| Active Product 2.1 | Experimental | Energy Product Form 2 - active product 1 |
|
| Placebo Control 3 | Placebo Comparator | Energy Product Form 3 - control |
| 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 cognitive function | Mean difference in cognitive function 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 at-home (direct-to-consumer) specimen assays |
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.
|
| Active Product 3.1 | Experimental | Energy Product Form 3 - active product 1 |
|
| Placebo Control 4 | Placebo Comparator | Energy Product Form 4 - control |
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| Active Product 4.1 | Experimental | Energy Product Form 4 - active product 1 |
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| Active Product 4.2 | Experimental | Energy Product Form 4 - active product 2 |
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| Active Product 4.3 | Experimental | Energy Product Form 4 - active product 3 |
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| Active Product 5.1.1 | Experimental | Energy Product Form 5.1 - active product 1 |
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| Placebo Control 5.1.0 | Placebo Comparator | Energy Product Form 5.1 - control |
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| Placebo Control 5.3.0 | Placebo Comparator | Energy Product Form 5.3 - control |
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| Active Product 5.3.1 | Experimental | Energy Product Form 5.3 - active product 1 |
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| Active Product 5.3.2 | Experimental | Energy Product Form 5.3 - active product 2 |
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| Placebo Control 5.2.0 | Placebo Comparator | Energy Product Form 5.2 - control |
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| Active Product 5.2.1 | Experimental | Energy Product Form 5.2 - active product 1 |
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| 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. |
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| 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. |
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| Energy Placebo Control Form 2 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 2 as directed for a period of 6 weeks. |
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| Energy Active Study Product 2.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 2.1 as directed for a period of 6 weeks. |
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| Energy Placebo Control Form 3 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 3 as directed for a period of 6 weeks. |
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| Energy Active Study Product 3.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 3.1 as directed for a period of 6 weeks. |
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| Energy Placebo Control Form 4 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 4 as directed for a period of 6 weeks. |
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| Energy Active Study Product 4.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 4.1 as directed for a period of 6 weeks. |
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| Energy Active Study Product 4.2 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 4.2 as directed for a period of 6 weeks. |
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| Energy Active Study Product 4.3 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 4.3 as directed for a period of 6 weeks. |
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| Energy Placebo Control Form 5.1.0 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 5.0 as directed for a period of 6 weeks. |
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| Energy Active Study Product 5.1.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 5.1.1 as directed for a period of 6 weeks. |
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| Energy Placebo Control Form 5.3.0 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 5.3 as directed for a period of 6 weeks. |
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| Energy Active Study Product 5.3.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 5.3.1 as directed for a period of 6 weeks. |
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| Energy Active Study Product 5.3.2 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 5.3.2 as directed for a period of 6 weeks. |
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| Energy Placebo Control Form 5.2.0 | Dietary Supplement | Participants will use their Radicle Energy Placebo Control Form 5.2 as directed for a period of 6 weeks. |
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| Energy Active Study Product 5.2.1 Usage | Dietary Supplement | Participants will use their Radicle Energy Active Study Product 5.2.1 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 |
| 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 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 |
Mean difference in specimen assays as surrogates and/or markers for health outcomes (Optional; among consented participants only) |
| 6 weeks |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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