AgingNCT03528538
The Efficacy of Fenugreek Supplementation on Men's Health
A study testing AlphaFen fenugreek 400 mg and AlphaFen fenugreek 500 mg in people with Aging and Testosterone Deficiency, run by Jacksonville University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Testosterone Deficiency
- What is being tested?
- AlphaFen fenugreek 400 mg and AlphaFen fenugreek 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men between the ages of 21- 45 that were recreationally active.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville University
Jacksonville, Florida, 32211
About this study
Official title: The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
- 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.
- 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.
- 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.
- Conditions
- Aging, Testosterone Deficiency
- Being tested
- AlphaFen fenugreek 400 mg, AlphaFen fenugreek 500 mg, Placebo
- Keywords
- Fenugreek, Aging Male Symptoms, Testosterone, Supplementation, Double Blind, Body Composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaFen fenugreek 400 mgDietary supplement
A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
AlphaFen fenugreek 500 mgDietary supplement
A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
PlaceboOther
rice flour in a vegetable/ cellulose capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| AlphaFen fenugreek 400 mg | Active comparator | This group received 400 mg of fenugreek to be ingested daily for 60 days. Receives: Dietary Supplement: AlphaFen fenugreek 400 mg |
| AlphaFen fenugreek 500 mg | Active comparator | This group received 500 mg of fenugreek to be ingested daily. Receives: Dietary Supplement: AlphaFen fenugreek 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life Questionnaire
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.
Measured: 8 weeks
Aging Male Symptoms Questionnaire
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.
Measured: 8 weeks
Blood
From 10 mL of fasted blood. The free testosterone, total testosterone, and estradiol levels will be extracted from the blood sample.
Measured: 8 weeks
Body Composition
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
Measured: 8 weeks
Strength
Hand grip dynamometer
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start19 Sep 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacksonville University
- Sponsor type
- University, hospital or other
- Collaborators
- SPECNOVA LLC
- Responsible party
- Sponsor
- Investigators
- Heather Hausenblaus, PhD, Principal investigator, Jacksonville University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528538
- Sponsor's protocol ID
- JUFenugreek2018
- Status last verified
- May 2018
- First submitted
- 26 Feb 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14675485Dempster 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.
PubMed 8614327Fess, E. E. (1992). Grip strength. In clinical assessment recommendations. 2nd ed. Chicago: American Society of Hand Therapists.
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.
PubMed 26791805Spielberger, 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.
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.
PubMed 21312304Wankhede 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.
PubMed 30356905Zack 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.
PubMed 24264499Hausenblas 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.
PubMed 32441668
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Fenugreek Supplementation on Men's Health: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03528538
- Acronym / sponsor ID
- JUFenugreek2018
- Conditions
- Aging, Testosterone Deficiency
- Keywords
- Fenugreek, Aging Male Symptoms, Testosterone, Supplementation, Double Blind, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jacksonville UniversityUniversity, hospital or other
- Collaborators
- SPECNOVA LLC
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| AlphaFen fenugreek 400 mg | Active comparator | Dietary Supplement: AlphaFen fenugreek 400 mgThis group received 400 mg of fenugreek to be ingested daily for 60 days. |
| AlphaFen fenugreek 500 mg | Active comparator | Dietary Supplement: AlphaFen fenugreek 500 mgThis group received 500 mg of fenugreek to be ingested daily. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men between the ages of 21- 45 that were recreationally active.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlphaFen fenugreek 400 mgA brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives. | Dietary supplement | AlphaFen fenugreek 400 mg |
| AlphaFen fenugreek 500 mgA brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives. | Dietary supplement | AlphaFen fenugreek 500 mg |
| Placeborice flour in a vegetable/ cellulose capsule | Other | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 14675485Daig 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.
- Background: PubMed 8614327Dempster 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.
- BackgroundFess, E. E. (1992). Grip strength. In clinical assessment recommendations. 2nd ed. Chicago: American Society of Hand Therapists.
- Background: PubMed 26791805Rao 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.
- BackgroundSpielberger, 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.
- Background: PubMed 21312304Steels 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.
- Background: PubMed 30356905Wankhede 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.
- Background: PubMed 24264499Zack 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.
- Derived from this study: PubMed 32441668Hausenblas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Hausenblaus, PhD principal investigator
Jacksonville University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlphaFen fenugreek 400 mg and AlphaFen fenugreek 500 mg in people with Aging and Testosterone Deficiency, run by Jacksonville University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life Questionnaire (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528538, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.