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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress 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 less stress (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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Relaxation Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Relaxation Product Form 1 - active product 1 |
|
| Placebo Control 2 | Placebo Comparator | Relaxation Product Form 2 - control |
|
| Active Product 2.1 | Experimental | Relaxation Product Form 2 - active product 1 |
|
| Placebo Control 3 | Placebo Comparator | Relaxation Product Form 3 - control |
|
| Active Product 3.1 | Experimental | Relaxation Product Form 3 - active product 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Control Form 1 | Dietary Supplement | Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in stress | Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Change in cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool | Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood all in one panel 1 outcome (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Values will vary based on optional biomarker selected |
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.
|
| Placebo Control 4 | Placebo Comparator | Relaxation Product Form 4 - control |
|
| Active Product 4.1 | Experimental | Relaxation Product Form 4 - active product 1 |
|
| Active Product 4.2 | Experimental | Relaxation Product Form 4 - active product 2 |
|
| Relaxation Active Study Product 1.1 | Dietary Supplement | Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Placebo Control Form 2 | Dietary Supplement | Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks. |
|
| Relaxation Active Study Product 2.1 | Dietary Supplement | Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks. |
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| Placebo Control Form 3 | Dietary Supplement | Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks. |
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| Relaxation Active Study Product 3.1 | Dietary Supplement | Participants will use their Radicle Relaxation Active Study Product 3.1 as directed for a period of 6 weeks. |
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| Placebo Control Form 4 | Dietary Supplement | Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks. |
|
| Relaxation Active Study Product 4.1 | Dietary Supplement | Participants will use their Radicle Relaxation Active Study Product 4.1 as directed for a period of 6 weeks. |
|
| Relaxation Active Study Product 4.2 | Dietary Supplement | Participants will use their Radicle Relaxation Active Study Product 4.2 as directed for a period of 6 weeks. |
|
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 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 |
| Minimal clinically important difference (MCID) in stress | Likelihood of experiencing minimal clinically important difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress) | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of experiencing minimal clinically important difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Minimal clinically important difference (MCID) in cognitive function | Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function) | 6 weeks |
| Minimal clinically important difference (MCID) in mood (emotional distress-depression) | Likelihood of experiencing minimal clinically important difference in emotional distress score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| 6 weeks |