DihydrotestosteroneNCT04298840
Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
A study testing Creatine Monohydrate Supplementation in people with Dihydrotestosterone and Testosterone, run by Texas Tech University at 1 site in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled trial examining the effects of creatine monohydrate supplementation on androgens and hair loss in free-living adult males. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dihydrotestosterone, Testosterone, Hair Loss
- What is being tested?
- Creatine Monohydrate Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2020to Feb 2021
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between the ages of 18 and 35
- Weight of at least 110 pounds
- Generally healthy (defined as an absence of a disease or medical condition which could potentially be negatively influenced by study participation or confound study results)
- Low levels of habitual creatine consumption, defined as consuming an average of <10 g/week of creatine from all supplemental sources within the three months prior to study initiation
- Willingness to report to baseline and final assessments with a similar haircut (i.e. willingness to replicate baseline haircut prior final assessment, to the best of his ability) and one that allows for evaluation of hair growth patterns (e.g., not a completely shaved head that disallows visualization of the hairline)
- Willingness to adhere to the supplementation protocol for the duration of the study (i.e., 6 months of daily supplementation with 5 grams per day of creatine monohydrate or placebo) and abstain from additional creatine supplement ingestion during this time.
- Willingness to abstain from any treatments related to hair loss or hair growth for the duration of the study
- Willingness to maintain normal practices regarding hair products (i.e. continue to use regular shampoo, conditioner, and other products over the duration of the study and abstain from switching products during the study if at all possible)
Who cannot join
- Failing to meet any of the aforementioned inclusion criteria
- Presence of pacemaker or any electrical device (due to electrical currents administered by bioimpedance devices used to assess body composition)
- Individual currently participates in any type of hair loss treatment or procedure or has undergone any such treatment or procedure within the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology & Sport Management
Lubbock, Texas, 79409
About this study
This study is a randomized, double-blind, placebo-controlled trial examining the effects of creatine monohydrate supplementation on androgens and hair loss in free-living adult males. Participants will complete 6 months of supplementation of 5 grams per day of creatine monohydrate while following their normal lifestyle practices. At baseline and six months after study initiation, participants will complete laboratory assessments. These assessments will include a standard blood draw for evaluation of total testosterone (T), free T, dihydrotestosterone (DHT), and DHT:T ratios in the blood, as well as global photography and questionnaires to evaluate hair loss. This study will examine the claim that creatine increases DHT concentrations and and DHT:T ratio, as well as provide novel data regarding whether creatine promotes hair loss.
- Conditions
- Dihydrotestosterone, Testosterone, Hair Loss
- Being tested
- Creatine Monohydrate Supplementation, Placebo Supplementation
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine Monohydrate SupplementationDietary supplement
Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.
Placebo SupplementationDietary supplement
Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate | Experimental | Not described Receives: Dietary Supplement: Creatine Monohydrate Supplementation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dihydrotestosterone
Blood concentration of dihydrotestosterone.
Measured: 6 months
Dihydrotestosterone-to-Testosterone Ratio 1
Ratio of dihydrotestosterone to total testosterone in the blood.
Measured: 6 months
Dihydrotestosterone-to-Testosterone Ratio 2
Ratio of dihydrotestosterone to free testosterone in the blood.
Measured: 6 months
Total Testosterone
Total testosterone in the blood.
Measured: 6 months
Free Testosterone
Free testosterone in the blood.
Measured: 6 months
Global Hair Assessments
Subjectively scored assessment of changes in hair properties from baseline to the end of the intervention. Assessor will be a blinded expert.
Measured: 6 months
Secondary outcomes (1)
Self-Reported Hair Assessments
Survey allowing for participant-reported changes in hair properties as a result of the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Sponsor indicated it was unable/unwilling to support project at the present time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DihydrotestosteroneStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Legion Athletics, Inc
- Responsible party
- Sponsor
- Investigators
- Grant M Tinsley, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298840
- Sponsor's protocol ID
- 2019-997
- Status last verified
- Sep 2021
- First submitted
- 4 Mar 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Merwe J, Brooks NE, Myburgh KH. Three weeks of creatine monohydrate supplementation affects dihydrotestosterone to testosterone ratio in college-aged rugby players. Clin J Sport Med. 2009 Sep;19(5):399-404. doi: 10.1097/JSM.0b013e3181b8b52f.
PubMed 19741313Kreider RB, Kalman DS, Antonio J, Ziegenfuss TN, Wildman R, Collins R, Candow DG, Kleiner SM, Almada AL, Lopez HL. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine. J Int Soc Sports Nutr. 2017 Jun 13;14:18. doi: 10.1186/s12970-017-0173-z. eCollection 2017.
PubMed 28615996Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. doi: 10.1016/s0303-7207(02)00372-6.
PubMed 12573818Trueb RM. Molecular mechanisms of androgenetic alopecia. Exp Gerontol. 2002 Aug-Sep;37(8-9):981-90. doi: 10.1016/s0531-5565(02)00093-1.
PubMed 12213548Bang HJ, Yang YJ, Lho DS, Lee WY, Sim WY, Chung BC. Comparative studies on level of androgens in hair and plasma with premature male-pattern baldness. J Dermatol Sci. 2004 Feb;34(1):11-6. doi: 10.1016/j.jdermsci.2003.11.005.
PubMed 14757277Olsen EA, Whiting DA, Savin R, Rodgers A, Johnson-Levonas AO, Round E, Rotonda J, Kaufman KD; Male Pattern Hair Loss Study Group. Global photographic assessment of men aged 18 to 60 years with male pattern hair loss receiving finasteride 1 mg or placebo. J Am Acad Dermatol. 2012 Sep;67(3):379-86. doi: 10.1016/j.jaad.2011.10.027. Epub 2012 Feb 9.
PubMed 22325459Van Neste MD. Assessment of hair loss: clinical relevance of hair growth evaluation methods. Clin Exp Dermatol. 2002 Jul;27(5):358-65. doi: 10.1046/j.1365-2230.2002.01003.x.
PubMed 12190635Ashique K, Kaliyadan F. Clinical photography for trichology practice: tips and tricks. Int J Trichology. 2011 Jan;3(1):7-13. doi: 10.4103/0974-7753.82118.
PubMed 21769229Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
PubMed 1188424Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.
PubMed 27081243
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
- ClinicalTrials.gov ID
- NCT04298840
- Acronym / sponsor ID
- 2019-997
- Conditions
- Dihydrotestosterone, Testosterone, Hair Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor indicated it was unable/unwilling to support project at the present time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Legion Athletics, Inc
- Study start
- Apr 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 6 Mar 2020 (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.
This study is a randomized, double-blind, placebo-controlled trial examining the effects of creatine monohydrate supplementation on androgens and hair loss in free-living adult males. Participants will complete 6 months of supplementation of 5 grams per day of creatine monohydrate while following their normal lifestyle practices. At baseline and six months after study initiation, participants will complete laboratory assessments. These assessments will include a standard blood draw for evaluation of total testosterone (T), free T, dihydrotestosterone (DHT), and DHT:T ratios in the blood, as well as global photography and questionnaires to evaluate hair loss. This study will examine the claim that creatine increases DHT concentrations and and DHT:T ratio, as well as provide novel data regarding whether creatine promotes hair loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate | Experimental | Dietary Supplement: Creatine Monohydrate Supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male between the ages of 18 and 35
- Weight of at least 110 pounds
- Generally healthy (defined as an absence of a disease or medical condition which could potentially be negatively influenced by study participation or confound study results)
- Low levels of habitual creatine consumption, defined as consuming an average of <10 g/week of creatine from all supplemental sources within the three months prior to study initiation
- Willingness to report to baseline and final assessments with a similar haircut (i.e. willingness to replicate baseline haircut prior final assessment, to the best of his ability) and one that allows for evaluation of hair growth patterns (e.g., not a completely shaved head that disallows visualization of the hairline)
Key exclusion criteria (3 listed)
- Failing to meet any of the aforementioned inclusion criteria
- Presence of pacemaker or any electrical device (due to electrical currents administered by bioimpedance devices used to assess body composition)
- Individual currently participates in any type of hair loss treatment or procedure or has undergone any such treatment or procedure within the last 12 months
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 |
|---|---|---|
| Creatine Monohydrate SupplementationParticipants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate. | Dietary supplement | Creatine Monohydrate |
| Placebo SupplementationParticipants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo. | Dietary supplement | Placebo |
Primary outcome
Dihydrotestosterone
Time frame: 6 months
Blood concentration of dihydrotestosterone.
Dihydrotestosterone-to-Testosterone Ratio 1
Time frame: 6 months
Ratio of dihydrotestosterone to total testosterone in the blood.
Dihydrotestosterone-to-Testosterone Ratio 2
Time frame: 6 months
Ratio of dihydrotestosterone to free testosterone in the blood.
Total Testosterone
Time frame: 6 months
Total testosterone in the blood.
Free Testosterone
Time frame: 6 months
Free testosterone in the blood.
Global Hair Assessments
Time frame: 6 months
Subjectively scored assessment of changes in hair properties from baseline to the end of the intervention. Assessor will be a blinded expert.
1 secondary outcome
Self-Reported Hair Assessments
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 19741313van der Merwe J, Brooks NE, Myburgh KH. Three weeks of creatine monohydrate supplementation affects dihydrotestosterone to testosterone ratio in college-aged rugby players. Clin J Sport Med. 2009 Sep;19(5):399-404. doi: 10.1097/JSM.0b013e3181b8b52f.
- Background: PubMed 28615996Kreider RB, Kalman DS, Antonio J, Ziegenfuss TN, Wildman R, Collins R, Candow DG, Kleiner SM, Almada AL, Lopez HL. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine. J Int Soc Sports Nutr. 2017 Jun 13;14:18. doi: 10.1186/s12970-017-0173-z. eCollection 2017.
- Background: PubMed 12573818Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. doi: 10.1016/s0303-7207(02)00372-6.
- Background: PubMed 12213548Trueb RM. Molecular mechanisms of androgenetic alopecia. Exp Gerontol. 2002 Aug-Sep;37(8-9):981-90. doi: 10.1016/s0531-5565(02)00093-1.
- Background: PubMed 14757277Bang HJ, Yang YJ, Lho DS, Lee WY, Sim WY, Chung BC. Comparative studies on level of androgens in hair and plasma with premature male-pattern baldness. J Dermatol Sci. 2004 Feb;34(1):11-6. doi: 10.1016/j.jdermsci.2003.11.005.
- Background: PubMed 22325459Olsen EA, Whiting DA, Savin R, Rodgers A, Johnson-Levonas AO, Round E, Rotonda J, Kaufman KD; Male Pattern Hair Loss Study Group. Global photographic assessment of men aged 18 to 60 years with male pattern hair loss receiving finasteride 1 mg or placebo. J Am Acad Dermatol. 2012 Sep;67(3):379-86. doi: 10.1016/j.jaad.2011.10.027. Epub 2012 Feb 9.
- Background: PubMed 12190635Van Neste MD. Assessment of hair loss: clinical relevance of hair growth evaluation methods. Clin Exp Dermatol. 2002 Jul;27(5):358-65. doi: 10.1046/j.1365-2230.2002.01003.x.
- Background: PubMed 21769229Ashique K, Kaliyadan F. Clinical photography for trichology practice: tips and tricks. Int J Trichology. 2011 Jan;3(1):7-13. doi: 10.4103/0974-7753.82118.
- Background: PubMed 1188424Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
- Background: PubMed 27081243Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.
- Individual participant dataSharing planned: No
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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.
Grant M Tinsley, PhD principal investigator
Texas Tech 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 Creatine Monohydrate Supplementation in people with Dihydrotestosterone and Testosterone, run by Texas Tech 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 8 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dihydrotestosterone (time frame: 6 months). The study lists 6 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 NCT04298840, which also lists 10 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 14 Sep 2021.