Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

NCT04298840 | Withdrawn

• 1 other identifier: 2019-997
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dihydrotestosterone; Testosterone; Hair Loss

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Self-Reported Hair Assessments

  6 months

Study Arms (2)

Creatine Monohydrate

EXPERIMENTAL

Dietary Supplement: Creatine Monohydrate Supplementation

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo Supplementation

Interventions

Creatine Monohydrate Supplementation DIETARY_SUPPLEMENT

Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.

Creatine Monohydrate

Placebo Supplementation DIETARY_SUPPLEMENT

Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Legion Athletics, Inc: collaborator

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

Related Publications (10)

• 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.

  PMID: 19741313 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.

  PMID: 28615996 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.

  PMID: 12573818 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.

  PMID: 12213548 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.

  PMID: 14757277 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.

  PMID: 22325459 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.

  PMID: 12190635 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.

  PMID: 21769229 BACKGROUND

• Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.

  PMID: 1188424 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.

  PMID: 27081243 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Grant M Tinsley, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: April 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)