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Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04298840
Recruitment Status : Withdrawn (Sponsor indicated it was unable/unwilling to support project at the present time.)
First Posted : March 6, 2020
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Legion Athletics, Inc
Information provided by (Responsible Party):
Texas Tech University

Study Description
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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
Dihydrotestosterone Testosterone Hair Loss Dietary Supplement: Creatine Monohydrate Supplementation Dietary Supplement: Placebo Supplementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Dihydrotestosterone [ Time Frame: 6 months ]
    Blood concentration of dihydrotestosterone.

  2. Dihydrotestosterone-to-Testosterone Ratio 1 [ Time Frame: 6 months ]
    Ratio of dihydrotestosterone to total testosterone in the blood.

  3. Dihydrotestosterone-to-Testosterone Ratio 2 [ Time Frame: 6 months ]
    Ratio of dihydrotestosterone to free testosterone in the blood.

  4. Total Testosterone [ Time Frame: 6 months ]
    Total testosterone in the blood.

  5. Free Testosterone [ Time Frame: 6 months ]
    Free testosterone in the blood.

  6. Global Hair Assessments [ Time Frame: 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 [ Time Frame: 6 months ]
    Survey allowing for participant-reported changes in hair properties as a result of the intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298840


Locations
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United States, Texas
Department of Kinesiology & Sport Management
Lubbock, Texas, United States, 79409
Sponsors and Collaborators
Texas Tech University
Legion Athletics, Inc
Investigators
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Principal Investigator: Grant M Tinsley, PhD Texas Tech University
More Information
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Publications:

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Responsible Party: Texas Tech University
ClinicalTrials.gov Identifier: NCT04298840    
Other Study ID Numbers: 2019-997
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical