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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety 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 feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) 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 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 | Calm Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Calm Product Form 1 - active product 1 |
|
| Placebo Control 6.1.0 | Placebo Comparator | Calm Product 6.1 - control |
|
| Active Product 6.1.1 | Experimental | Calm Product 6.1 - 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 feelings of anxiety | Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stress | Mean difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) | 6 weeks |
| Change in sleep | Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1) | Mean difference in saliva concentration as assessed by saliva-based IgG (Immunoglobulin) biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2) |
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.
| Calm Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Placebo Control 6.1 | Dietary Supplement | Participants will use their Placebo Control 6.1 as directed for a period of 6 weeks. |
|
| Calm Active Study Product 6.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 6.1 as directed for a period of 6 weeks. |
|
| 6 weeks |
| Change in mood (emotional distress) | Mean difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of achieving a MCID in sleep disturbance, as measured by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) | 6 weeks |
| Minimal clinically important difference (MCID) in stress | Likelihood of experiencing minimal clinically important difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) | 6 weeks |
| Minimal clinically important difference (MCID) in sleep | Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) | 6 weeks |
| Minimal clinically important difference (MCID) in mood (emotional distress) | Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) | 6 weeks |
Mean difference in saliva concentration as assessed by saliva-based cytokines (Interleukin 1 beta, Interleukin 8, Tumor necrosis factor-alpha, and Interleukin 6) biomarker. (Optional; among consented participants only). |
| 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3) | Mean difference in saliva concentration as assessed by saliva-based dehydroepiandrosterone sulfate (DHEA-S) biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (4) | Mean difference in saliva concentration as assessed by saliva-based estradiol biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (5) | Mean difference in saliva concentration as assessed by saliva-based progesterone biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (6) | Mean difference in saliva concentration as assessed by saliva-based testosterone biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (7) | Mean difference in saliva concentration as assessed by saliva-based cortisol biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (8) | Mean difference in saliva concentration as assessed by saliva-based melatonin biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (9) | Mean difference in saliva concentration as assessed by saliva-based C-Reactive Protein (CRP) biomarker. (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (1) | Mean difference in blood concentration as assessed by blood-based cortisol biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (2) | Mean difference in blood concentration as assessed by blood-based homocysteine biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (3) | Mean difference in blood concentration as assessed by blood-based ferritin biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (4) | Mean difference in blood concentration as assessed by blood-based thyroid stimulating hormone (TSH) biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (5) | Mean difference in blood concentration as assessed by blood-based hemoglobin A1C (HbA1c) biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (6) | Mean difference in blood concentration as assessed by blood-based insulin biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (7) | Mean difference in blood concentration as assessed by blood-based vitamin D biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (8) | Mean difference in blood concentration as assessed by blood-based dehydroepiandrosterone sulfate (DHEA-S) biomarker (1 drop). (Optional; among consented male participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (9) | Mean difference in blood concentration as assessed by blood-based testosterone biomarker (1 drop) (Optional; among consented male participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (10) | Mean difference in blood concentration as assessed by blood-based estradiol biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (11) | Mean difference in blood concentration as assessed by blood-based follicle-stimulating hormone (FSH) biomarker (1 drop). (Optional; among consented female participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (12) | Mean difference in blood concentration as assessed by blood-based total cholesterol (high-density lipoproteins (HDL) and low-density lipoproteins (LDL)) biomarker (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (13) | Mean difference in blood concentration as assessed by blood-based triglycerides (apolipoprotein A1 (ApoA1) and apolipoprotein B (ApoB)) (1 drop). (Optional; among consented participants only). | 6 weeks |
| Change in stool concentration of at-home (direct-to-consumer) specimen assay | Mean difference in stool concentration as assessed by a stool sample (microbial diversity) (Optional; among consented participants only). | 6 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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