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The Efficacy of Fenugreek Supplementation on Men's Health

Not Applicable
Completed
Conditions
Testosterone Deficiency
Aging
Interventions
Other: Placebo
Dietary Supplement: AlphaFen fenugreek 500 mg
Dietary Supplement: AlphaFen fenugreek 400 mg
Registration Number
NCT03528538
Lead Sponsor
Jacksonville University
Brief Summary

1. 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.

2. 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.

3. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
58
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
AlphaFen fenugreek 500 mgAlphaFen fenugreek 500 mgThis group received 500 mg of fenugreek to be ingested daily.
AlphaFen fenugreek 400 mgAlphaFen fenugreek 400 mgThis group received 400 mg of fenugreek to be ingested daily for 60 days.
Primary Outcome Measures
NameTimeMethod
Strength9 weeks

Hand grip dynamometer

Blood8 weeks

From 10 mL of fasted blood. The free testosterone, total testosterone, and estradiol levels will be extracted from the blood sample.

Health Related Quality of Life Questionnaire8 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 Composition8 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 Questionnaire8 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jacksonville University

🇺🇸

Jacksonville, Florida, United States

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