Skip to main content
OpenTrials
Completed

NCT Number: NCT03528538

The Efficacy of Fenugreek Supplementation on Men's Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Testosterone Deficiency

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jacksonville University

Jacksonville, Florida, 32211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AlphaFen fenugreek 400 mg

Dietary Supplement

A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.

AlphaFen fenugreek 500 mg

Dietary Supplement

A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.

Placebo

Other

rice flour in a vegetable/ cellulose capsule

Primary outcomes

  1. Health Related Quality of Life Questionnaire

    Time frame: 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.

  2. Aging Male Symptoms Questionnaire

    Time frame: 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.

  3. Blood

    Time frame: 8 weeks

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

  4. Body Composition

    Time frame: 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

  5. Strength

    Time frame: 9 weeks

    Hand grip dynamometer

Sponsors and collaborators

Lead sponsor

Jacksonville University

Other

Collaborators

  • SPECNOVA LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 18, 2018
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.