Influence of Creatine Monohydrate Supplementation on Androgens and Global Hair Assessments
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Global Hair Assessments
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Global Hair Assessments
时间窗: 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
时间窗: 6 months
Free testosterone in the blood.
Dihydrotestosterone
时间窗: 6 months
Blood concentration of dihydrotestosterone.
Total Testosterone
时间窗: 6 months
Total testosterone in the blood.
Dihydrotestosterone-to-Testosterone Ratio 1
时间窗: 6 months
Ratio of dihydrotestosterone to total testosterone in the blood.
Dihydrotestosterone-to-Testosterone Ratio 2
时间窗: 6 months
Ratio of dihydrotestosterone to free testosterone in the blood.
次要结局
- Self-Reported Hair Assessments(6 months)