Investigating the effects of creatine supplementation on serum testosterone, dihydrotestosterone levels, and hair density in strength athletes: A double-blind clinical trial study
The aim of this study is to investigate the effects of creatine supplementation on male pattern baldness (androgenetic alopecia) in male athletes.
Design
This study is designed as a randomized, double-blind, parallel clinical trial.
Settings and conduct
Conducted in-person at the Iran Center for Dermatology and Hair Research.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Gender: Males aged between 18 and 45 years.
General Health: Healthy individuals without chronic diseases or metabolic disorders.
Hair Loss Status: Participants must not exhibit early signs of male pattern baldness (androgenetic alopecia).
Athletic Status: Participants must have been regularly engaged in resistance training (e.g., bodybuilding) for at least one year.
No Recent Supplement Use: Participants must not have used any creatine supplements or hair loss-related medications for at least one month prior to the study.
Exclusion Criteria:
History of Hair-Related Diseases: Individuals with skin diseases or conditions that could affect hair loss, such as alopecia areata.
Current Medication or Supplement Use: Individuals currently taking medications affecting hormones or other supplements related to hair loss.
specific medical conditions that could interfere with creatine supplementation.
Intervention groups
Creatine Supplement Group: Participants in this group will receive a creatine supplement.
Placebo Group: Participants in this group will receive a placebo
Main outcome variables
Change in hair density;
Rate of progression or reduction in male pattern baldness;
Changes in serum testosterone and dihydrotestosterone levels;
Adverse effects related to creatine or placebo consumption.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240814062762N1
Registration date:2024-08-31, 1403/06/10
Registration timing:prospective
Last update:2024-08-31, 1403/06/10
Update count:0
Registration date
2024-08-31, 1403/06/10
Registrant information
Name
Mohammadyasin Lak
Name of organization / entity
Sport Sciences Research Institute of Iran, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6609 1745
Email address
yasinlakifbb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-01, 1403/07/10
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of creatine supplementation on serum testosterone, dihydrotestosterone levels, and hair density in strength athletes: A double-blind clinical trial study
Public title
The effects of creatine supplementation on male pattern baldness in male resistance athletes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
General Health Status: Healthy individuals without chronic diseases or metabolic disorders.
Male Pattern Baldness: Participants must not exhibit early signs of male pattern baldness (androgenetic alopecia).
Sporting Activity: Individuals must have been regularly engaged in resistance training (e.g., bodybuilding) for at least one year.
No Recent Supplement Use: Individuals must not have used any creatine supplements or hair loss-related medications (such as finasteride or minoxidil) for at least one month prior to the study.
Exclusion criteria:
History of Hair-Related Diseases: Individuals with skin diseases or other conditions that could affect hair loss, such as alopecia areata.
Current Medication or Supplement Use: Current users of medications affecting hormones or other supplements related to hair loss.
Advanced Hair Loss: Individuals with advanced hair loss (Norwood stage 5 or above), which could complicate study outcomes.
Age
From 18 years old to 40 years old
Gender
Male
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants are randomly assigned to two groups: the intervention group (receiving creatine) and the control group (receiving a placebo). To ensure accuracy and reliability in this process, standard randomization methods have been employed. For example, the researchers have utilized computer software to generate random numbers, which determines the group assignment for each participant. These methods guarantee that the allocation of participants to groups is entirely random, with no bias or influence from external factors.
In this study, no quasi-random methods, such as assignment based on birth date, odd or even numbers, or any predetermined pattern, have been used. Such methods are considered non-random allocation and do not provide the same level of validity as full randomization.
Overall, to maintain scientific rigor and minimize bias, the researchers have ensured that the assignment of participants to the intervention and control groups is carried out completely randomly, using validated randomization methods.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding has been carefully designed to ensure that several groups involved are unaware of the allocation to the intervention and control groups:
Participants: The participants are unaware of whether they have been assigned to the intervention group (receiving creatine) or the control group (receiving a placebo). This blinding is achieved by using supplement and placebo capsules that are identical in appearance, with no distinguishable differences for the participants.
Principal Investigator: The principal investigator, responsible for the overall management of the study, is also blinded to the participants' group assignments. This blinding is implemented to prevent any bias in the interpretation and analysis of the data.
These blinding procedures are crucial for maintaining the scientific integrity of the study and minimizing any potential bias throughout the research process. It is important to note that participants are fully informed about their involvement in the study, and adequate information has been provided to them. The lack of awareness regarding group allocation does not imply that participants are unaware of their participation in the study, and it does not in any way violate ethical research principles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee/Research Ethics Working Group of the Schools of Health, Nutrition, and Food Science
Street address
Karimkhan Zand Boulevard, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
07132305410
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1403.021
Health conditions studied
1
Description of health condition studied
Hairloss
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in hair density based on counting the number of hair strands in a specific area of the scalp, using standard imaging techniques at different time points (before the intervention and three months after the intervention).
Timepoint
before the intervention and three months after the intervention
Method of measurement
using standard imaging techniques
Secondary outcomes
1
Description
Changes in serum hormone levels: Measurement of changes in testosterone, dihydrotestosterone (DHT), and other related hormones at different time points throughout the study.Hair loss rate: Assessment of the extent of hair loss using standard imaging techniques in specific areas of the scalp, conducted at various time intervals before and after the intervention.
Timepoint
After 3 months
Method of measurement
Use of standard imaging techniques/blood tests
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive a daily standard dose of creatine supplement. This dosage is determined based on common and safe guidelines for creatine consumption in athletes.
Category
Lifestyle
2
Description
Control group: Participants in the control group will receive a daily standard dose of a placebo supplement containing 5 grams of maltodextrin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
the Iran Center for Dermatology and Hair Research.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Individual Participant Data:
Description: Individual participant data, including demographic information, hormonal test results, and hair loss assessments.
Data Sharing Details: These data will be shared after full anonymization (removal of any personally identifiable information). Only data related to primary outcomes (such as hair density and hormonal changes) will be shared.
Statistical Analysis Results:
Description: Files containing statistical analysis results related to the effects of creatine supplementation on the study's primary outcomes.
Data Sharing Details: These data will be shared in full and without any restrictions, making them accessible to researchers and the scientific community.
Study Protocol:
Description: The complete study protocol, including methods, design, and inclusion/exclusion criteria.
Data Sharing Details: This protocol will be shared after the study's completion and will be made available for use by other researchers.
Reports Related to Secondary Outcomes:
Description: Information and results related to secondary outcomes, such as minor changes in other health parameters.
Data Sharing Details: This information will be shared selectively, based on requests from other researchers.
When the data will become available and for how long
After Study Completion
To whom data/document is available
University Professors, Researchers
Under which criteria data/document could be used
If it can be useful for future studies and provide guidance for them
From where data/document is obtainable
Send an email to Yasinlakifbb@yahoo.com
What processes are involved for a request to access data/document