Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.
This is a randomized, 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 improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, 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 during 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Rest Product Form 1 - control |
|
| Placebo Control 2 | Placebo Comparator | Rest Product Form 2 - control |
|
| Active Product 1.1 | Experimental | Rest Product Form 1 - active product 1 |
|
| Active Product 1.2 | Experimental | Rest Product Form 1 - active product 2 |
|
| Active Product 2.1 | Experimental | Rest Product Form 2 - active product 1 |
|
| Active Product 2.2 | Experimental | Rest Product Form 2 - active product 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rest Study Active Product 1.1 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep disturbance | Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fatigue | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 6 weeks |
| Change in cognitive function | Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
Not provided
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be stratified based on sex at birth then randomized to one of the study arms
Not provided
Not provided
The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
|
| Placebo Control 3 | Placebo Comparator | Rest Product Form 3 - control |
|
| Active Product 3.1 | Experimental | Rest Product Form 3 - active product 1 |
|
| Placebo Control 4 | Placebo Comparator | Rest Product Form 4 - control |
|
| Active Product 4.1 | Experimental | Rest Product Form 4 - active product 1 |
|
| Active Product 4.2 | Experimental | Rest Product Form 4 - active product 2 |
|
| Active Product 4.3 | Experimental | Rest Product Form 4 - active product 3 |
|
| Rest Study Active Product 1.2 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 2.1 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 2.2 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks. |
|
| Placebo Control Form 1 | Dietary Supplement | Participants will use Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Placebo Control Form 2 | Dietary Supplement | Participants will use Placebo Control Form 2 as directed for a period of 6 weeks. |
|
| Placebo Control Form 3 | Dietary Supplement | Participants will use Placebo Control Form 3 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 3.1 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks. |
|
| Placebo Control Form 4 | Dietary Supplement | Participants will use Placebo Control Form 4 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 4.1 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 4.2 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks. |
|
| Rest Study Active Product 4.3 Usage | Dietary Supplement | Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks. |
|
| 6 weeks |
| Change in anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Change in mood (emotional distress) | Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression) | 6 weeks |
| Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest) | 6 weeks |
| Minimal clinical importance difference (MCID) in sleep disturbance | Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance) | 6 weeks |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided