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

Sponsor

906 CMVI Holdings (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05862519

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Libido Intimacy Gastrointestinal Issues	Dietary Supplement: Reset Dietary Supplement: Stay Ready Fiber Dietary Supplement: Libido Dietary Supplement: Testosterone supplement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 14, 2023

Anticipated Primary Completion Date :

Jun 6, 2023

Anticipated Study Completion Date :

Jun 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants will begin taking the Reset supplement for 5 days. Then there will be a 2-day break with no products taken (wash out period). Participants will then begin taking the following 2 supplements: Stay Ready Fiber and libido with a partial overlap of products. Stay Ready Fiber will be taken from day 7 through 21, three capsules will be taken twice daily in the morning and afternoon. Libido will be taken from day 7 through 28, 2 capsules will be taken daily, preferably with a meal. Participants will then begin taking the Testosterone supplement. Testosterone will be taken from day 28 through to 84, 2 capsules will be taken daily, preferably with a meal.	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. Other Names: Pure for Men Reset Supplement Dietary Supplement: 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. Other Names: Pure for Men Stay Ready Fiber Capsules Dietary Supplement: 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. Other Names: Pure for Men Pump Enhancer Dietary Supplement: Testosterone supplement Supplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84. Other Names: Pure for Men T-Support

Arm

Intervention/Treatment

Experimental: Intervention Group

Participants will begin taking the Reset supplement for 5 days. Then there will be a 2-day break with no products taken (wash out period). Participants will then begin taking the following 2 supplements: Stay Ready Fiber and libido with a partial overlap of products. Stay Ready Fiber will be taken from day 7 through 21, three capsules will be taken twice daily in the morning and afternoon. Libido will be taken from day 7 through 28, 2 capsules will be taken daily, preferably with a meal. Participants will then begin taking the Testosterone supplement. Testosterone will be taken from day 28 through to 84, 2 capsules will be taken daily, preferably with a meal.

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.

Other Names:

Pure for Men Reset Supplement

Dietary Supplement: 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.

Other Names:

Pure for Men Stay Ready Fiber Capsules

Dietary Supplement: 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.

Other Names:

Pure for Men Pump Enhancer

Dietary Supplement: Testosterone supplement

Supplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84.

Other Names:

Pure for Men T-Support

Outcome Measures

Primary Outcome Measures

Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks] [12 weeks]
Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.

Secondary Outcome Measures

Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks] [12 weeks]
Survey-based assessment (0-5 scale) of changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

906 CMVI Holdings
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

906 CMVI Holdings

ClinicalTrials.gov Identifier:

NCT05862519

Other Study ID Numbers:

20287

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Testosterone

Study Results

No Results Posted as of May 17, 2023