Creatine Supplementation and Resistance Training in Premenopausal Females
Condition: Health Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Creatine Monohydrate Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Creatine monohydrate; resistance training; menstrual cycle; female physiology; body composition