Clinical trial NCT04298840: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Dihydrotestosterone
Testosterone
Hair Loss
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Legion Athletics, Inc
First posted: 2020-03-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Dihydrotestosterone
timeFrame: 6 months
measure: Dihydrotestosterone-to-Testosterone Ratio 1
timeFrame: 6 months
measure: Dihydrotestosterone-to-Testosterone Ratio 2
timeFrame: 6 months
measure: Total Testosterone
timeFrame: 6 months
measure: Free Testosterone
timeFrame: 6 months
measure: Global Hair Assessments
timeFrame: 6 months
Secondary outcomes:
measure: Self-Reported Hair Assessments
timeFrame: 6 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Department of Kinesiology & Sport Management
state: Texas
Study officials:
affiliation: Texas Tech University
name: Grant M Tinsley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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