Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

Sponsor
Texas Tech University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04298840
Collaborator
Legion Athletics, Inc (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Creatine Monohydrate Supplementation
  • Dietary Supplement: Placebo Supplementation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.Participants will be randomized to receive creatine monohydrate or placebo for daily consumption during the study period.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Creatine Monohydrate

Dietary Supplement: Creatine Monohydrate Supplementation
Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.

Placebo Comparator: Placebo

Dietary Supplement: Placebo Supplementation
Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.

Outcome Measures

Primary Outcome Measures

  1. Dihydrotestosterone [6 months]

    Blood concentration of dihydrotestosterone.

  2. Dihydrotestosterone-to-Testosterone Ratio 1 [6 months]

    Ratio of dihydrotestosterone to total testosterone in the blood.

  3. Dihydrotestosterone-to-Testosterone Ratio 2 [6 months]

    Ratio of dihydrotestosterone to free testosterone in the blood.

  4. Total Testosterone [6 months]

    Total testosterone in the blood.

  5. Free Testosterone [6 months]

    Free testosterone in the blood.

  6. 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.

Secondary Outcome Measures

  1. Self-Reported Hair Assessments [6 months]

    Survey allowing for participant-reported changes in hair properties as a result of the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Kinesiology & Sport Management Lubbock Texas United States 79409

Sponsors and Collaborators

  • Texas Tech University
  • Legion Athletics, Inc

Investigators

  • Principal Investigator: Grant M Tinsley, PhD, Texas Tech University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Texas Tech University
ClinicalTrials.gov Identifier:
NCT04298840
Other Study ID Numbers:
  • 2019-997
First Posted:
Mar 6, 2020
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021