The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Blood
研究概览
简要总结
- The problem: There is limited research on the use of herbal supplements in general, and fenugreek specifically, to improve male health, particularly to increase testosterone levels. As well, no located studies have examined the effects of fenugreek supplementation on healthy men's health-related quality of life, anxiety levels, and body composition.
- Relevant research examined the effects of fenugreek supplementation with healthy men aged between 43 and 70 years of age. The researchers found that both total serum testosterone and free testosterone increased compared to placebo after 12 weeks of active treatment. The researchers concluded that fenugreek supplementation was a safe and effective treatment for reducing symptoms of possible androgen deficiency, improves sexual function and increases serum testosterone in healthy middle-aged to older men. Another study found that fenugreek supplementation improved aging male symptoms and testosterone levels remained in a normal range in healthy men aged 25 to 45 years.
- The importance of this study: The importance of this study is to help determine if fenugreek supplementation affects testosterone levels, body composition, health-related quality of life, anxiety, and aging symptoms in healthy men aged 21 - 45 years.
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
- Double (Participant, Investigator)
盲法说明
The investigators and the participants remained blind until after the total completion of the experiment.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men between the ages of 21- 45 that were recreationally active.
排除标准
- •Above 30% body composition, not in the age range, history of asthma, diabetes, hypoglycemia, or took any hormonal supplements such as testosterone or anabolic steroids.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
AlphaFen fenugreek 400 mg
This group received 400 mg of fenugreek to be ingested daily for 60 days.
干预措施: AlphaFen fenugreek 400 mg (Dietary Supplement)
AlphaFen fenugreek 500 mg
This group received 500 mg of fenugreek to be ingested daily.
干预措施: AlphaFen fenugreek 500 mg (Dietary Supplement)
结局指标
主要结局
Blood
时间窗: 8 weeks
From 10 mL of fasted blood. The free testosterone, total testosterone, and estradiol levels will be extracted from the blood sample.
Strength
时间窗: 9 weeks
Hand grip dynamometer
Health Related Quality of Life Questionnaire
时间窗: 8 weeks
The Centers for Disease Control (CDC) Health-related Quality of Life measure will be used to assess health-related quality of life. This scale has excellent psychometric properties. The HRQoL assesses the positive and negative aspects of a person's life such as satisfaction or distress and the impact of these factors to their perceived health and life experience. This questionnaire is a valid and reliable measure than can be used to evaluate the individuals physical and mental perceptions.
Body Composition
时间窗: 8 weeks
The BODPOD machine is considered the gold standard for body composition as it has a range of error between ± 1 to 2.7% and is easier to complete than underwater weighing. The BODPOD was used to observe body composition at each assessment
Aging Male Symptoms Questionnaire
时间窗: 8 weeks
The Aging Male Questionnaire consists of 17 questions in 3 sub-scales (i.e., psychological, somatic and sexual) that assesses symptoms of aging specific for men. These sub-scales as well as the total score were used to assess symptoms. Having symptoms from the AMS questionnaire merely suggests a male may have deficiencies but blood samples are the best determinants of this condition. The higher the score, the worst the outcome.
次要结局
未报告次要终点