The Efficacy of Fenugreek Supplementation on Men's Health

NCT ID: NCT03528538

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2017-12-15

Brief Summary

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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

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Conditions

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Aging Testosterone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The investigators and the participants remained blind until after the total completion of the experiment.

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

rice flour in a vegetable/ cellulose capsule

AlphaFen fenugreek 400 mg

This group received 400 mg of fenugreek to be ingested daily for 60 days.

Group Type ACTIVE_COMPARATOR

AlphaFen fenugreek 400 mg

Intervention Type DIETARY_SUPPLEMENT

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

AlphaFen fenugreek 500 mg

This group received 500 mg of fenugreek to be ingested daily.

Group Type ACTIVE_COMPARATOR

AlphaFen fenugreek 500 mg

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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AlphaFen fenugreek 400 mg

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

Intervention Type DIETARY_SUPPLEMENT

AlphaFen fenugreek 500 mg

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

rice flour in a vegetable/ cellulose capsule

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SPECNOVA LLC

UNKNOWN

Sponsor Role collaborator

Jacksonville University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Hausenblaus, PhD

Role: PRINCIPAL_INVESTIGATOR

Jacksonville University

Locations

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Jacksonville University

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14675485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8614327 (View on PubMed)

Fess, E. E. (1992). Grip strength. In clinical assessment recommendations. 2nd ed. Chicago: American Society of Hand Therapists.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26791805 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21312304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30356905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24264499 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32441668 (View on PubMed)

Other Identifiers

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JUFenugreek2018

Identifier Type: -

Identifier Source: org_study_id

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