A Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

Libido Clinical Trial

Official title:

A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05862519
• Other study ID #: 20287
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: June 13, 2023

Study information

• Verified date: May 2023
• Source: 906 CMVI Holdings
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 13, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Male (biological at birth) within the LGBTQIA+ community

• Aged between 18-44

• Generally healthy - don't live with any uncontrolled chronic disease

• Generally active lifestyle or seeking to achieve health improvement

• Sexually active with a partner

Exclusion Criteria:

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

• Anyone with known severe allergic reactions.

• Unwilling to follow the study protocol.

• Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g. eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder)

• Current substance abuse disorder

• Diagnosis of an autoimmune disease, such as multiple sclerosis and rheumatoid arthritis

• Self-reported or diagnosed high blood pressure or hypotension (BP < 90 over 60)

• Currently, or in the past 6 months, undergoing hormone therapy

• Any medical condition that is unstable or uncontrolled

• A history of sexual trauma or abuse

• Has introduced any new prescription medication or supplements within the past 12 weeks that influence gastrointestinal issues, libido, or testosterone production.

Related Conditions & MeSH terms

• Libido

Intervention

Dietary Supplement:
• Reset
Pure for Men Reset is a Vegan, Proprietary Blend of Toxin Eliminating Cleanser: Cascara Sagrada Bark, Senna Leaf, Psyllium Husk, Licorice Root, and Aloe Vera Gel. Taken on Day 1 to Day 5.
• Stay Ready Fiber
Stay Ready Fiber is a Vegan, 100% Natural, Proprietary Blend of Digestive Aids: Psyllium Husk, Aloe Vera Extract, Chia Seeds & Flaxseed. Taken from Day 7 through Day 21.
• Libido
Supplement designed to support endurance and increased arousal. Contains L-Citrulline, L-Arginine and Black Pepper Fruit Extract (Piper Nigrum). Taken from Day 7 through to Day 28.
• Testosterone supplement
Supplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
906 CMVI Holdings	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]	Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.	12 weeks
Secondary	Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks]	Survey-based assessment (0-5 scale) of changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life.	12 weeks