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Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

T

Texas Tech University

Status

Withdrawn

Conditions

Hair Loss
Testosterone
Dihydrotestosterone

Treatments

Dietary Supplement: Creatine Monohydrate Supplementation
Dietary Supplement: Placebo Supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT04298840
2019-997

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Creatine Monohydrate
Experimental group
Treatment:
Dietary Supplement: Creatine Monohydrate Supplementation
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo Supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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