Health and Wellness Products for Sexual Health

Overseen By Study Manager

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Cardiac dysfunction, Liver disease, Kidney disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, cancer treatments, sleep aids, seizure medications, and others. If you are on any of these, you may need to stop them to participate.

What makes the Spark Active Study Product 2.1 treatment unique for sexual health?

The Spark Active Study Product 2.1 treatment is unique because it involves a novel approach using different forms of placebo controls, which may help in understanding the psychological and physiological effects of the treatment. This approach is different from standard treatments that may not use such comprehensive placebo controls. ^{1 2 3 4 5}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sexual health and related health outcomes

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science

Eligibility Criteria

This trial is for men interested in improving sexual health and satisfaction. Participants should be experiencing some level of sexual dysfunction or dissatisfaction. The specific eligibility criteria are not provided, but typically include age range, general health status, and the nature of their sexual dysfunction.

Inclusion Criteria

Resides in the United States

I am a male aged 21 or older.

Endorses as improved libido (sex drive), sexual satisfaction and/or function as a primary desire

Exclusion Criteria

Unable to read and understand English

I cannot provide a valid US address and mobile number.

Reports current enrollment in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

No in-person visits; all assessments are electronic

Follow-up

Participants are monitored for safety and effectiveness after treatment through a final survey

1 week

Treatment Details

Interventions

• Spark Active Study Product 2.1
• Spark Placebo Control Form 1
• Spark Placebo Control Form 2

Trial Overview The study is testing the effects of two different 'Spark' active products against two placebo controls on men's sexual health and related outcomes. It's a randomized trial meaning participants are randomly assigned to one of the four groups without choice.

Participant Groups

Group I: Active Product 2.1 Experimental Treatment 1 Intervention

Spark Product Form 2 - active product 1

Group II: Active Product 1.1 Experimental Treatment 1 Intervention

Spark Product Form 1 - active product 1

Group III: Placebo Control 1 Placebo Group 1 Intervention

Spark Product Form 1 - control

Group IV: Placebo Control 2 Placebo Group 1 Intervention

Spark Product Form 2 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

A pilot study involving 39 college students assessed the feasibility of using a real-time respiratory-based biofeedback device alongside mindfulness training, but found low adherence to the device and collaboration with the company, which hindered the study's effectiveness.

While all participants showed improvement in stress levels over time, there was no additional benefit from using the biofeedback device compared to mindfulness training alone, suggesting that the device did not enhance the intervention outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial. Lin, B., Prickett, C., Woltering, S.[2021]

Participants at moderate-to-high risk of developing type 2 diabetes engaged with real-time feedback from wearable technologies, which increased their self-awareness about how their lifestyle choices affected their health.

While some individuals changed their behaviors based on the feedback from the glucose and activity monitors, many did not, indicating a need for better training and support to help users effectively utilize the information for sustained lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital lifestyle behaviour change intervention for the prevention of type 2 diabetes: a qualitative study exploring intuitive engagement with real-time glucose and physical activity feedback. Whelan, ME., Denton, F., Bourne, CLA., et al.[2021]

In a 12-month feasibility study involving 16 participants aged 55-74 with obesity and elevated cardiovascular risk, the use of a Polar M430 activity tracker showed high adherence, with an average of 292 valid wear days (80% of the study duration).

Participants reported that the tracker helped them monitor their physical activity and heart rate, but issues like measurement inaccuracies and design preferences affected their experience, suggesting that better instructions and more appealing designs could enhance wear time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. Henriksen, A., Sand, AS., Deraas, T., et al.[2020]

Engaging consumers in health research is crucial for improving recruitment and retention strategies, as it aligns research with the needs and preferences of potential participants.

Projects that incorporate consumer input are often viewed more favorably by funding bodies and ethics committees, highlighting the importance of stakeholder involvement in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of consumer involvement in research. Halcomb, L.[2017]

Participants in the primary intervention group maintained higher levels of moderate to vigorous physical activity (MVPA) 12 weeks after the intervention, although their sitting time slightly increased, indicating some sustainability of activity levels.

The waitlist control group, after receiving only the Garmin Vivofit 2 activity tracker, showed a significant increase in MVPA and a reduction in sedentary behavior, suggesting that wearable technology alone can effectively promote physical activity changes in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A digital lifestyle behaviour change intervention for the prevention of type 2 diabetes: a qualitative study exploring intuitive engagement with real-time glucose and physical activity feedback. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The value of consumer involvement in research. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial. [2020]