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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Change in muscle strength with time-of-day and menstrual cycle phase [Срок оценки: 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.]

Вторичные конечные точки (12)

• Change in cognitive performance with time-of-day and menstrual cycle phase [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07399847 · FHM-2025-5797-RECR-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗