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The Efficacy of Fenugreek Supplementation on Men's Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528538
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
SPECNOVA LLC
Information provided by (Responsible Party):
Jacksonville University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Testosterone Deficiency Dietary Supplement: AlphaFen fenugreek 400 mg Dietary Supplement: AlphaFen fenugreek 500 mg Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: The investigators and the participants remained blind until after the total completion of the experiment.
Primary Purpose: Treatment
Official Title: The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fenugreek

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528538


Locations
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United States, Florida
Jacksonville University
Jacksonville, Florida, United States, 32211
Sponsors and Collaborators
Jacksonville University
SPECNOVA LLC
Investigators
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Principal Investigator: Heather Hausenblaus, PhD Jacksonville University
More Information
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Publications:
Fess, E. E. (1992). Grip strength. In clinical assessment recommendations. 2nd ed. Chicago: American Society of Hand Therapists.
Spielberger, CD., Gorsuch, R.L., Lushene, R., Vagg, P.R., & Jacobs, G.A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jacksonville University
ClinicalTrials.gov Identifier: NCT03528538    
Other Study ID Numbers: JUFenugreek2018
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacksonville University:
Fenugreek
Aging Male Symptoms
Testosterone
 Supplementation
Double Blind
Body Composition
Additional relevant MeSH terms:
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Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs