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A randomized, double-blind, placebo-controlled, direct-to-consumer 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 (sex drive), 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 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 5.1.0 | Placebo Comparator | Spark Product 5.1 - control |
|
| Active Product 5.1.1 | Experimental | Spark Product 5.1 - active product 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spark Placebo Control 5.1 | Dietary Supplement | Participants will use their Radicle Spark Placebo Product 5.1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sexual health | Mean difference in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Full Profile Sexual Function and Satisfaction Survey (Female) (where lower scores correspond to lower sexual function and 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:
Report being pregnant, trying to become pregnant, or breastfeeding
Unable to provide a valid US shipping address and mobile phone number
Reports current enrollment in another clinical trial
Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
Unable to read and understand English
Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
Lack of reliable daily access to the internet
Assigned sex at birth is female
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| 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 5.1 Usage | Dietary Supplement | Participants will use their Radicle Spark Active Study Product 5.1 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) Full Profile Sexual Function and Satisfaction Survey (Female) (where lower scores correspond to lower sexual function and 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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