A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Stay Ready Fiber (Dietary Supplement)
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.
干预措施: Libido (Dietary Supplement)
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.
干预措施: Testosterone supplement (Dietary Supplement)
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.
干预措施: Reset (Dietary Supplement)
结局指标
主要结局
Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
时间窗: 12 weeks
Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.
次要结局
- Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks](12 weeks)