The Efficacy of Fenugreek Supplementation on Men's Health

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial

Conditions
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Aging, Testosterone Deficiency

Intervention / Treatment
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* Dietary Supplement: AlphaFen fenugreek 400 mg
* Dietary Supplement: AlphaFen fenugreek 500 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men between the ages of 21- 45 that were recreationally active. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will complete 3 assessments during the study at Day 0, Week 4, and Week 8. At each assessment, they complete the following: self-report inventories (e.g., Aging Male Symptoms Questionnaire, Trait Anxiety Inventory, Health-related Quality of Life), body composition via BOD POD, heart rate, blood pressure, and blood draws. The subjects will be randomized to one of the following three conditions: (1) AlphaFenTM fenugreek (400 mg/d), (2) AlphaFenTM fenugreek (500 mg/d), or (2) placebo control. The subjects will be asked to take one capsule of the fenugreek supplement or placebo daily for eight weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* rice flour in a vegetable/ cellulose capsule<br>|
| Active Comparator: AlphaFen fenugreek 400 mg<br>This group received 400 mg of fenugreek to be ingested daily for 60 days. | Dietary Supplement: AlphaFen fenugreek 400 mg<br>* A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.<br>|
| Active Comparator: AlphaFen fenugreek 500 mg<br>This group received 500 mg of fenugreek to be ingested daily. | Dietary Supplement: AlphaFen fenugreek 500 mg<br>* A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life Questionnaire | 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. | 8 weeks | 
| Aging Male Symptoms Questionnaire | 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. | 8 weeks | 
| Blood | From 10 mL of fasted blood. The free testosterone, total testosterone, and estradiol levels will be extracted from the blood sample. | 8 weeks | 
| Body Composition | 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 | 8 weeks | 
| Strength | Hand grip dynamometer | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenugreek, Aging Male Symptoms, Testosterone, Supplementation, Double Blind, Body Composition