Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

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 Overview

• Status: Withdrawn
• Conditions: Hair Loss; Dihydrotestosterone; Testosterone
• Intervention / Treatment: Dietary supplement: Creatine Monohydrate Supplementation; Dietary supplement: Placebo Supplementation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • Department of Kinesiology & Sport Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo Supplementation; Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.
Experimental: Creatine Monohydrate	Dietary supplement: Creatine Monohydrate Supplementation; Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: Legion Athletics, Inc

Publications and helpful links

General Publications

• Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
• 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.
• 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.
• Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. doi: 10.1016/s0303-7207(02)00372-6.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: 2019-997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No