Hair Loss Clinical Trial
Official title:
Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
NCT number | NCT04298840 |
Other study ID # | 2019-997 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2020 |
Est. completion date | February 2021 |
Verified date | September 2021 |
Source | Texas Tech University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Department of Kinesiology & Sport Management | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University | Legion Athletics, Inc |
United States,
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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
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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 |
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