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Sponsor indicated it was unable/unwilling to support project at the present time.
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| Name | Class |
|---|---|
| Legion Athletics, Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine Monohydrate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine Monohydrate Supplementation | Dietary Supplement | Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dihydrotestosterone | Blood concentration of dihydrotestosterone. | 6 months |
| Dihydrotestosterone-to-Testosterone Ratio 1 | Ratio of dihydrotestosterone to total testosterone in the blood. | 6 months |
| Dihydrotestosterone-to-Testosterone Ratio 2 | Ratio of dihydrotestosterone to free testosterone in the blood. | 6 months |
| Total Testosterone | Total testosterone in the blood. | 6 months |
| Free Testosterone | Free testosterone in the blood. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Hair Assessments | Survey allowing for participant-reported changes in hair properties as a result of the intervention. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant M Tinsley, PhD | Texas Tech University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Kinesiology & Sport Management | Lubbock | Texas | 79409 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19741313 | Background | 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. | |
| 28615996 | Background | Kreider 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. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
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| Placebo Supplementation | Dietary Supplement | Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo. |
|
| 12573818 | Background | Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. doi: 10.1016/s0303-7207(02)00372-6. |
| 12213548 | Background | Trueb RM. Molecular mechanisms of androgenetic alopecia. Exp Gerontol. 2002 Aug-Sep;37(8-9):981-90. doi: 10.1016/s0531-5565(02)00093-1. |
| 14757277 | Background | Bang 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. |
| 22325459 | Background | Olsen 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. |
| 12190635 | Background | Van 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. |
| 21769229 | Background | Ashique 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. |
| 1188424 | Background | Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009. |
| 27081243 | Background | Gupta 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |