NCT06596928已完成不适用
A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Free and Total Testosterone Levels
研究概览
简要总结
This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male (biological at birth).
- •Aged between 30-
- •Generally healthy - do not live with any uncontrolled chronic disease such as diabetes or hypertension.
- •Willing to provide blood draws during the study duration.
- •Fitness/wellness enthusiast who has the same weekly exercise routine i.e. HIIT, strength training, or running >3 times per week.
- •Self-reported concerns with energy levels, mood, and libido and sexual performance/adequacy.
- •Willing to avoid medications, supplements, or vitamins aimed at increasing testosterone levels for the duration of the study.
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 requiring the use of an Epi-Pen.
- •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.
- •Any medical condition that is unstable or uncontrolled.
- •Has introduced any new prescription medication or supplements within the past 12 weeks that influence testosterone production.
- •History of testicular or prostate cancer.
- •Previously has undergone a vasectomy.
- •Currently undergoing hormone replacement therapy (HRT)
- •Currently taking performance-enhancing drugs.
- •Anyone taking prescription blood pressure, immunosuppressants, sleeping aids, anti-seizure, and/or thyroid medications.
- •Living in New York, Rhode Island, Hawaii, or Alaska.
结局指标
主要结局
Change in Free and Total Testosterone Levels
时间窗: Baseline, Day 45, Day 90
This study will measure the changes in free and total testosterone levels in male participants. Blood samples will be collected at Baseline, Day 45, and Day 90. The primary goal is to assess the effectiveness of the test supplement in increasing testosterone levels compared to the placebo group.
次要结局
- Change in Cognitive Function, Mood, Energy, and Sexual Function(Baseline, Day 45, Day 90)
研究者
研究点 (2)
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