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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sexual health 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 improved libido, sexual satisfaction and/or function, (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 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 | Spark Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Spark Product Form 1 - active product 1 |
|
| Placebo Control 2 | Placebo Comparator | Spark Product Form 2 - control |
|
| Active Product 2.1 | Experimental | Spark Product Form 2 - active product 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spark Placebo Control Form 1 | Dietary Supplement | Participants will use their Radicle Spark Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sexual health | Difference between rates of change over time in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Brief Profile Sexual Function and Satisfaction Survey [male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)] | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of stress | Mean difference in feelings of 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 fatigue |
| 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:
Assigned sex at birth is male
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science | 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 their age and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
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The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
| Spark Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle Spark Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Spark Placebo Control Form 2 | Dietary Supplement | Participants will use their Radicle Spark Placebo Control Form 2 as directed for a period of 6 weeks. |
|
| Spark Active Study Product 2.1 Usage | Dietary Supplement | Participants will use their Radicle Spark Active Study Product 2.1 as directed for a period of 6 weeks. |
|
Mean difference in fatigue as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
| 6 weeks |
| Change in mood (emotional distress-depression) | Mean difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; where higher scores correspond to more severe emotional distress-depression) | 6 weeks |
| Minimal clinical importance difference (MCID) in sexual health | Likelihood of achieving a MCID in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Brief Profile Sexual Function and Satisfaction Survey [male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)] | 6 weeks |
| Minimal clinical importance difference (MCID) in feelings of stress | Likelihood of achieving a MCID in feelings of stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress) | 6 weeks |
| Minimal clinical importance difference (MCID) in fatigue | Likelihood of achieving a MCID in feelings of fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 6 weeks |
| Minimal clinical importance difference (MCID) in mood (emotional distress-depression) | Likelihood of achieving a MCID in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; where higher scores correspond to more severe emotional distress-depression) | 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 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 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 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 (12) | 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 |
|---|---|
| D009948 | Orgasm |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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