Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
Primary Purpose
Dihydrotestosterone, Testosterone, Hair Loss
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creatine Monohydrate Supplementation
Placebo Supplementation
Sponsored by
About this trial
This is an interventional other trial for Dihydrotestosterone
Eligibility Criteria
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
Sites / Locations
- Department of Kinesiology & Sport Management
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Creatine Monohydrate
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Dihydrotestosterone
Blood concentration of dihydrotestosterone.
Dihydrotestosterone-to-Testosterone Ratio 1
Ratio of dihydrotestosterone to total testosterone in the blood.
Dihydrotestosterone-to-Testosterone Ratio 2
Ratio of dihydrotestosterone to free testosterone in the blood.
Total Testosterone
Total testosterone in the blood.
Free Testosterone
Free testosterone in the blood.
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.
Secondary Outcome Measures
Self-Reported Hair Assessments
Survey allowing for participant-reported changes in hair properties as a result of the intervention.
Full Information
NCT ID
NCT04298840
First Posted
March 4, 2020
Last Updated
September 7, 2021
Sponsor
Texas Tech University
Collaborators
Legion Athletics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04298840
Brief Title
Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
Official Title
Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor indicated it was unable/unwilling to support project at the present time.
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
Collaborators
Legion Athletics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dihydrotestosterone, Testosterone, Hair Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine Monohydrate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Monohydrate Supplementation
Intervention Description
Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Supplementation
Intervention Description
Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.
Primary Outcome Measure Information:
Title
Dihydrotestosterone
Description
Blood concentration of dihydrotestosterone.
Time Frame
6 months
Title
Dihydrotestosterone-to-Testosterone Ratio 1
Description
Ratio of dihydrotestosterone to total testosterone in the blood.
Time Frame
6 months
Title
Dihydrotestosterone-to-Testosterone Ratio 2
Description
Ratio of dihydrotestosterone to free testosterone in the blood.
Time Frame
6 months
Title
Total Testosterone
Description
Total testosterone in the blood.
Time Frame
6 months
Title
Free Testosterone
Description
Free testosterone in the blood.
Time Frame
6 months
Title
Global Hair Assessments
Description
Subjectively scored assessment of changes in hair properties from baseline to the end of the intervention. Assessor will be a blinded expert.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-Reported Hair Assessments
Description
Survey allowing for participant-reported changes in hair properties as a result of the intervention.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant M Tinsley, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Kinesiology & Sport Management
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19741313
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.
Results Reference
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PubMed Identifier
28615996
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.
Results Reference
background
PubMed Identifier
12573818
Citation
Kaufman KD. Androgens and alopecia. Mol Cell Endocrinol. 2002 Dec 30;198(1-2):89-95. doi: 10.1016/s0303-7207(02)00372-6.
Results Reference
background
PubMed Identifier
12213548
Citation
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.
Results Reference
background
PubMed Identifier
14757277
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. doi: 10.1016/j.jdermsci.2003.11.005.
Results Reference
background
PubMed Identifier
22325459
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.
Results Reference
background
PubMed Identifier
12190635
Citation
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.
Results Reference
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PubMed Identifier
21769229
Citation
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.
Results Reference
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PubMed Identifier
1188424
Citation
Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009.
Results Reference
background
PubMed Identifier
27081243
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.
Results Reference
background
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Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
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