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The Efficacy of Fenugreek Supplementation on Men's Health

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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

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE September 19, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • 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.
  • 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.
  • 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.
  • 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
  • Strength [ Time Frame: 9 weeks ]
    Hand grip dynamometer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Fenugreek Supplementation on Men's Health
Official Title  ICMJE The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Aging
  • Testosterone Deficiency
Intervention  ICMJE
  • Dietary Supplement: AlphaFen fenugreek 400 mg
    A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
  • Dietary Supplement: AlphaFen fenugreek 500 mg
    A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
  • Other: Placebo
    rice flour in a vegetable/ cellulose capsule
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Active Comparator: AlphaFen fenugreek 400 mg
    This group received 400 mg of fenugreek to be ingested daily for 60 days.
    Intervention: Dietary Supplement: AlphaFen fenugreek 400 mg
  • Active Comparator: AlphaFen fenugreek 500 mg
    This group received 500 mg of fenugreek to be ingested daily.
    Intervention: Dietary Supplement: AlphaFen fenugreek 500 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528538
Other Study ID Numbers  ICMJE JUFenugreek2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jacksonville University
Study Sponsor  ICMJE Jacksonville University
Collaborators  ICMJE SPECNOVA LLC
Investigators  ICMJE
Principal Investigator: Heather Hausenblaus, PhD Jacksonville University
PRS Account Jacksonville University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP