Dihydrotestosterone, Hair Loss, Testosterone
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCreatine Monohydrate Supplementation
Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.
DIETARY_SUPPLEMENTPlacebo Supplementation
Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.
Sponsors
Legion Athletics, Inc
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dihydrotestosterone | 6 months | Blood concentration of dihydrotestosterone. |
| Global Hair Assessments | 6 months | Subjectively scored assessment of changes in hair properties from baseline to the end of the intervention. Assessor will be a blinded expert. |
| Total Testosterone | 6 months | Total testosterone in the blood. |
| Free Testosterone | 6 months | Free testosterone in the blood. |
| Dihydrotestosterone-to-Testosterone Ratio 1 | 6 months | Ratio of dihydrotestosterone to total testosterone in the blood. |
| Dihydrotestosterone-to-Testosterone Ratio 2 | 6 months | Ratio of dihydrotestosterone to free testosterone in the blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Hair Assessments | 6 months | Survey allowing for participant-reported changes in hair properties as a result of the intervention. |
Countries
United States
Outcome results
None listed