跳至主要内容
临床试验/NCT05745870
NCT05745870已完成1 期

Effects of Creatine Supplementation and Resistance Training on Lean Mass, Sleep, Muscular Strength, and Perceived Menstrual Cycle Symptoms in Premenopausal Females

University of Idaho2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
27
试验地点
2
主要终点
Body Composition

研究概览

简要总结

The goal of this clinical trial is to determine the effects of creatine monohydrate and resistance training on lean mass, sleep, muscular strength, and perceived menstrual cycle symptoms in untrained premenopausal females. The main questions it aims to answer are: 1) Does creatine monohydrate supplementation improve body composition, muscular strength, and sleep? 2) Does creatine monohydrate decrease perceived menstrual cycle symptoms compared to a placebo control?

Participants will be asked to consume creatine monohydrate daily for 42 consecutive days and well as perform a daily ovulation test. Pre and post testing will include assessments of urine specific gravity to determine hydration status, body composition testing, muscular strength testing and questionnaires.

Researchers will compare creatine monohydrate supplementation to a maltodextrin control to see if body composition, sleep, muscular strength, and perceived menstrual cycle symptoms are improved following 6-weeks.

详细描述

This study will be a 6 week creatine monohydrate and resistance training intervention with performance familiarization and pre and post testing. Participants will report to the Human Performance Laboratory (HPL), having fasted from alcohol, caffeine, and exercise for a minimum of 12-hours, for pre testing and to sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then provide one urine sample to determine proper hydration status for body composition assessment. Next, participants will complete a physical activity readiness questionnaire (PARQ+) prior to performing any physical tasks. Participants will complete a daily menstrual cycle log, fatigue questionnaire, and health history survey. Prior to body composition testing, participants will complete a dual-energy x-ray apsorptiometry (DXA) scan consent for to ensure absence of pregnancy. Then, a full-body DXA scan will be completed along with an InBody bioelectrical impedance analysis. Following body composition testing, participants will be fitted for an Oura ring to track their sleep. Lastly, muscular strength will be assessed using the Tonal. Following a 5-minute full-body warm up, 1-repetition maximum will be determined using two upper body and two lower body exercises at maximal effort. Upon conclusion of pre-testing, participants will be randomized into two groups: 1) creatine monohydrate (5g/d creatine monohydrate + 5g/d maltodextrin) or 2) placebo (10 g/d maltodextrin) for 42 consecutive days. Participants will visit the HPL daily to consume their respective supplement as well as provide a urine sample for ovulation status determination. Additionally, participants will complete two resistance training sessions on non-consecutive days using the Tonal per week for 6-weeks. Following 6-weeks, post-testing will occur and includes the same procedures as pre-testing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • premenopausal females 18-25 yrs
  • able to resistance train with no contraindications to exercise testing

排除标准

  • premenopausal female taking hormonal contraceptives
  • premenopausal females who are resistance training >2x/wk
  • premenopausal females who consume creatine monohydrate

结局指标

主要结局

Body Composition

时间窗: 42 days

Change in lean mass (kg, %) using a DXA scan from baseline after 42 days

Sleep

时间窗: 42 days

Change in sleep (hours, minutes, REM) using the Oura Ring application tracking from baseline after 42 days

Muscular Strength

时间窗: 42 days

Change in muscular strength (1-repetition maximum) using the Tonal from baseline after 42 days

Perceived Menstrual Cycle Symptoms

时间窗: 42 days

Change in perceived menstrual cycle symptoms (fatigue, cramping, bloating) using menstrual cycle questionnaires from baseline after 42 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Brown

Associate Professor

University of Idaho

研究点 (2)

Loading locations...

相似试验