The Efficacy of Fenugreek Supplementation on Men's Health

May 16, 2018 updated by: Jacksonville University

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32211
        • Jacksonville University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks
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
8 weeks
Strength
Time Frame: 9 weeks
Hand grip dynamometer
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacksonville University

Collaborators

SPECNOVA LLC

Investigators

  • Principal Investigator: Heather Hausenblaus, PhD, Jacksonville University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUFenugreek2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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