Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

Hair Loss Clinical Trial

Official title:

Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04298840
• Other study ID #: 2019-997
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: February 2021

Study information

• Verified date: September 2021
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Dihydrotestosterone
• Hair Loss
• Testosterone

Intervention

Dietary Supplement:
• Creatine Monohydrate Supplementation
Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.
• Placebo Supplementation
Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.

Locations

Country	Name	City	State
United States	Department of Kinesiology & Sport Management	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Legion Athletics, Inc

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. Review. — View Citation

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. Review. — View Citation

Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. — View Citation

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. — View Citation

Trüeb RM. Molecular mechanisms of androgenetic alopecia. Exp Gerontol. 2002 Aug-Sep;37(8-9):981-90. Review. — View Citation

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. — View Citation

Van Neste MD. Assessment of hair loss: clinical relevance of hair growth evaluation methods. Clin Exp Dermatol. 2002 Jul;27(5):358-65. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dihydrotestosterone	Blood concentration of dihydrotestosterone.	6 months
Primary	Dihydrotestosterone-to-Testosterone Ratio 1	Ratio of dihydrotestosterone to total testosterone in the blood.	6 months
Primary	Dihydrotestosterone-to-Testosterone Ratio 2	Ratio of dihydrotestosterone to free testosterone in the blood.	6 months
Primary	Total Testosterone	Total testosterone in the blood.	6 months
Primary	Free Testosterone	Free testosterone in the blood.	6 months
Primary	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	Self-Reported Hair Assessments	Survey allowing for participant-reported changes in hair properties as a result of the intervention.	6 months