Clinical trial NCT03528538: The Efficacy of Fenugreek Supplementation on Men's Health
Official title: The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Testosterone Deficiency
Keywords: Fenugreek
Aging Male Symptoms
Testosterone
Supplementation
Double Blind
Body Composition
Lead sponsor: Jacksonville University
Sponsor class: OTHER
Collaborators: name: SPECNOVA LLC
First posted: 2018-05-18
Enrollment: 58
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Health Related Quality of Life Questionnaire
timeFrame: 8 weeks
measure: Aging Male Symptoms Questionnaire
timeFrame: 8 weeks
measure: Blood
timeFrame: 8 weeks
measure: Body Composition
timeFrame: 8 weeks
measure: Strength
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville University
state: Florida
Study officials:
affiliation: Jacksonville University
name: Heather Hausenblaus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daig I, Heinemann LA, Kim S, Leungwattanakij S, Badia X, Myon E, Moore C, Saad F, Potthoff P, Thai do M. The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics. Health Qual Life Outcomes. 2003 Dec 15;1:77. doi: 10.1186/1477-7525-1-77.
citation: Dempster P, Aitkens S. A new air displacement method for the determination of human body composition. Med Sci Sports Exerc. 1995 Dec;27(12):1692-7.
citation: Fess, E. E. (1992). Grip strength. In clinical assessment recommendations. 2nd ed. Chicago: American Society of Hand Therapists.
citation: Rao A, Steels E, Inder WJ, Abraham S, Vitetta L. Testofen, a specialised Trigonella foenum-graecum seed extract reduces age-related symptoms of androgen decrease, increases testosterone levels and improves sexual function in healthy aging males in a double-blind randomised clinical study. Aging Male. 2016 Jun;19(2):134-42. doi: 10.3109/13685538.2015.1135323. Epub 2016 Jan 20.
citation: 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.
citation: Steels E, Rao A, Vitetta L. Physiological aspects of male libido enhanced by standardized Trigonella foenum-graecum extract and mineral formulation. Phytother Res. 2011 Sep;25(9):1294-300. doi: 10.1002/ptr.3360. Epub 2011 Feb 10.
citation: Wankhede S, Mohan V, Thakurdesai P. Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training: A randomized controlled pilot study. J Sport Health Sci. 2016 Jun;5(2):176-182. doi: 10.1016/j.jshs.2014.09.005. Epub 2015 Mar 7.
citation: Zack MM; Centers for Disease Control and Prevention (CDC). Health-related quality of life - United States, 2006 and 2010. MMWR Suppl. 2013 Nov 22;62(3):105-11.
citation: Hausenblas HA, Conway KL, Coyle KRM, Barton E, Smith LD, Esposito M, Harvey C, Oakes D, Hooper DR. Efficacy of fenugreek seed extract on men's psychological and physical health: a randomized placebo-controlled double-blind clinical trial. J Complement Integr Med. 2020 May 22;18(2):445-448. doi: 10.1515/jcim-2019-0101.