Sexual Function, Sexual Satisfaction
Conditions
Brief summary
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sexual health and related health outcomes
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSpark Placebo Control Form 1
Participants will use their Radicle Spark Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTSpark Active Study Product 1.1 Usage
Participants will use their Radicle Spark Active Study Product 1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTSpark Placebo Control Form 2
Participants will use their Radicle Spark Placebo Control Form 2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTSpark Active Study Product 2.1 Usage
Participants will use their Radicle Spark Active Study Product 2.1 as directed for a period of 6 weeks.
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities: Assigned sex at birth is male * Resides in the United States * Endorses as improved libido (sex drive), sexual satisfaction and/or function as a primary desire * Has the opportunity for at least 30% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Exclusion criteria
* 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: NYHA (New York Heart Health) Class Ill 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. 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, MAOls (monoamine oxidase inhibitors), 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual health | 6 weeks | 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 \[male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | 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) |
| Change in mood (emotional distress-depression) | 6 weeks | 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) |
| Minimal clinical importance difference (MCID) in sexual health | 6 weeks | 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 \[male version consists of 4 health domains assessed only among participants with sexual activity in the 30 days prior: erectile function (score range = 2-10; higher scores indicate better erectile function), orgasm ability (score range = 1-5; higher scores indicate more ability), orgasm pleasure (score range = 1-5; higher scores indicate more pleasure), satisfaction with sex life (score range = 2-10; higher scores indicate more satisfaction)\] |
| Change in feelings of stress | 6 weeks | 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) |
| Minimal clinical importance difference (MCID) in fatigue | 6 weeks | 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) |
| Minimal clinical importance difference (MCID) in mood (emotional distress-depression) | 6 weeks | 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) |
| Minimal clinical importance difference (MCID) in feelings of stress | 6 weeks | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (9) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based C-Reactive Protein (CRP) biomarker. (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (1) | 6 weeks | Mean difference in blood concentration as assessed by blood-based cortisol biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (2) | 6 weeks | Mean difference in blood concentration as assessed by blood-based homocysteine biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (3) | 6 weeks | Mean difference in blood concentration as assessed by blood-based ferritin biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (4) | 6 weeks | Mean difference in blood concentration as assessed by blood-based thyroid stimulating hormone (TSH) biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (5) | 6 weeks | Mean difference in blood concentration as assessed by blood-based hemoglobin A1C (HbA1c) biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (6) | 6 weeks | Mean difference in blood concentration as assessed by blood-based insulin biomarker (1 drop). (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based IgG (Immunoglobulin) biomarker (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (8) | 6 weeks | Mean difference in blood concentration as assessed by blood-based dehydroepiandrosterone sulfate (DHEA-S) biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (9) | 6 weeks | Mean difference in blood concentration as assessed by blood-based testosterone biomarker (1 drop) (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (10) | 6 weeks | Mean difference in blood concentration as assessed by blood-based estradiol biomarker (1 drop). (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (11) | 6 weeks | 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). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (12) | 6 weeks | 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). |
| Change in stool concentration of at-home (direct-to-consumer) specimen assay | 6 weeks | Mean difference in stool concentration as assessed by a stool sample (microbial diversity) (Optional; among consented participants only). |
| Change in blood concentration of at-home (direct-to-consumer) specimen assay (7) | 6 weeks | Mean difference in blood concentration as assessed by blood-based vitamin D biomarker (1 drop). (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2) | 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). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based dehydroepiandrosterone sulfate (DHEA-S) biomarker. (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (4) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based estradiol biomarker. (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (5) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based progesterone biomarker. (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (6) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based testosterone biomarker. (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (7) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based cortisol biomarker. (Optional; among consented participants only). |
| Change in saliva concentration of at-home (direct-to-consumer) specimen assay (8) | 6 weeks | Mean difference in saliva concentration as assessed by saliva-based melatonin biomarker. (Optional; among consented participants only). |
Countries
United States
Outcome results
None listed