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临床试验/NCT07399847
NCT07399847尚未招募不适用

Effects of Time-of-day and Menstrual Cycle Phase (Low and High Progesterone) on Female's Cognitive and Strength Performance

Lancaster University0 个研究点目标入组 30 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Change in muscle strength with time-of-day and menstrual cycle phase

研究概览

简要总结

This study is designed to determine whether time-of-day and menstrual cycle phase influence athletic performance and is expected to contribute valuable insight into how both time-of-day, and hormonal factors can influence performance and expand existing research. This study aims to support more inclusive, effective and personalised approaches to training and competition schedules for female athletes.

The study will involve two testing days that require a participant to complete a compilation of tests at 07:00, 12:00 and 18:00 hours. The testing days will be arranged for when a participant is in phase 1 (lowest levels of progesterone in the menstrual cycle) and phase 4 (highest level of progesterone in the menstrual cycle). The tests will examine a participant's executive function and physical strength.

This study will aim to recruit thirty 18-30-year-old females from Lancaster University who identify with a sport that they train ~3 times a week for with a purpose to compete. The females recruited must have a regular menstrual cycle and no history of sleep disorders.

Aim: To investigate the effects of time-of-day and menstrual cycle phase (low and high progesterone levels) on executive function and strength in females.

Objectives:

  1. To determine the effects of time-of-day on executive function and strength tests.
  2. To determine the effects of menstrual cycle phase on executive function and strength tests.
  3. To examine if there is an interaction between time-of-day and menstrual cycle phase on executive function and strength tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female (assigned at birth)
  • Aged 18-30 years
  • Tier 2 athlete which requires the participants to identify with a specific sport, train with a purpose to compete, regularly train ~3 times per week and compete at a local level (for example being a member of a BUCS sport and competing regularly with that sport)
  • Regular menstrual cycle - considered between 21-35-day cycles with at least 9 periods a year.

排除标准

  • The current/previous (in the last 3 months) use of any contraceptive method that alter the menstrual cycle
  • The use of the emergency contraceptive pill either 3 months prior to the study or during the study
  • Diagnosis of menstrual disorders including (but not exclusively) endometriosis and Polycystic Ovary Syndrome (PCOS)
  • A formal diagnosis of sleep disorders such as insomnia
  • Consume >400mg/day of caffeine
  • A musculoskeletal injury in the past 3 months
  • A formal diagnosis of neurological or psychiatric disorders such as Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Dyslexia or schizophrenia
  • Taking prescribed medication that may affect sleep for example stimulants such as Methylphenidate
  • No regular night shift work
  • No trans-meridian travel within 10 days of their expected participation dates (travel that will cause jetlag)
  • Have given blood in the last 12 weeks - this is not strictly an exclusion; participants will just need to wait until after 12 weeks before taking part in the study

研究组 & 干预措施

Female participants

Female (assigned at birth), aged 18-30 years. They must be tier 2 athletes which requires the participants to identify with a sport, train with a purpose to compete, regularly train ~3 times per week and compete at a local level. The participants must have a regular menstrual cycle - considered between 21-35-day cycles with at least 9 periods a year.

Participants must not be currently/previously (in the last 3 months) using of any contraceptive method that alter the menstrual cycle or used the emergency contraceptive pill either 3 months prior to the study or during the study.

结局指标

主要结局

Change in muscle strength with time-of-day and menstrual cycle phase

时间窗: 07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.

Repeated measures of strength at 07:00, 12:00 and 18:00 hours in phase 1 and 4 of the menstrual cycle. Handgrip strength requires participants to maximally squeeze the dynamometer for 3-seconds. 3 repeats will be carried out with the participants dominant hand, with 1-minutes of rest between each, recording the maximal values to determine both peak and mean values. Participants would also perform both countermovement and squat jumps, measuring flight time (seconds) and vertical jump height (centimetres). Each jump type will be repeated 3 times with a rest interval of 30-seconds between each jump repetition and a 2-minute rest interval between jump types. Maximal isometric Voluntary contraction of knee extensors and flexors would be measured over 4-seconds at 60° flexion. Between away and towards contractions, participants will have 30-seconds and between each set, they will have 3-minutes passive recovery.

次要结局

  • Change in cognitive performance with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in menstrual cycle symptoms with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Ovulation phase confirmation(Prior to testing visit and the following menstrual cycle. The day to begin ovulation testing varies depending on menstrual cycle length (21-35 days) but typically will begin around day 10 of each cycle, with day 1 being the first day of bleeding.)
  • Change in participant weight with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in hormone levels with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in core body temperature with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in blood pressure with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in heart rate variability with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in brain activity with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Changes in temporality with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Changes in inflammatory markers with time-of-day and menstrual cycle phase(07:00, 12:00 and 18:00 hours in phase 1 and 4 (the points of low and high progesterone) of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Change in glucose and lactate blood levels in the morning with menstrual cycle phase(07:00 hours in phase 1 and 4 of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Monitoring of participant diet intake(On the days of both testing visits, phase 1 and 4 of the menstrual cycle (each cycle lasting 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Changes in sleep quality with menstrual cycle phase(07:00 hours across phase 1 and 4 of the menstrual cycle (each cycle 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Changes in mood states with time-of-day and menstrual cycle phase.(07:00, 12:00 and 18:00 hours across phase 1 and 4 of the menstrual cycle (cycle of 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Changes in caffeine withdrawal symptoms with time-of-day and menstrual cycle phase.(07:00, 12:00 and 18:00 hours across phase 1 and 4 of the menstrual cycle (each cycle is 21-35 days). Phase 1 is during menstruation and phase 4 is +7 days (±1) after the confirmation of the luteinising hormone peak.)
  • Screening of general health to ensure eligibility(The familiarisation visit will take place 1-2 weeks before the testing visit. Whether a participant is tested in phase 1 or 4 (this is randomised) will dictate when the familiarisation visit will occur.)
  • Screening for menstrual cycle irregularities to confirm eligibility.(The familiarisation visit will take place 1-2 weeks before the testing visit. Whether a participant is tested in phase 1 or 4 (this is randomised) will dictate when the familiarisation visit will occur.)
  • Determination of participant chronotype.(The familiarisation visit will take place 1-2 weeks before the testing visit. Whether a participant is tested in phase 1 or 4 (this is randomised) will dictate when the familiarisation visit will occur.)
  • Screening of participants caffeine consumption to ensure eligibility(The familiarisation visit will take place 1-2 weeks before the testing visit. Whether a participant is tested in phase 1 or 4 (this is randomised) will dictate when the familiarisation visit will occur.)

研究者

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

Dr. Chris Gaffney

Senior Lecturer in Integrative Physiology

Lancaster University

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