Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

Not Applicable

Withdrawn

• Conditions: Dihydrotestosterone; Testosterone; Hair Loss
• Interventions: Dietary Supplement: Creatine Monohydrate Supplementation; Dietary Supplement: Placebo Supplementation

• Registration Number: NCT04298840
• Lead Sponsor: Texas Tech University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2020-04
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Creatine Monohydrate	Creatine Monohydrate Supplementation	-
Placebo	Placebo Supplementation	-

Primary Outcome Measures

Name	Time	Method
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.
Free Testosterone	6 months	Free testosterone in the blood.
Dihydrotestosterone	6 months	Blood concentration of dihydrotestosterone.
Total Testosterone	6 months	Total 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 Outcome Measures

Name	Time	Method
Self-Reported Hair Assessments	6 months	Survey allowing for participant-reported changes in hair properties as a result of the intervention.

Trial Locations

Locations (1)

Department of Kinesiology & Sport Management; 🇺🇸 Lubbock, Texas, United States