Myths and Methodologies: Reducing scientific design ambiguity in studies comparing sexes and/or menstrual cycle phases.
Stacy T Sims, Alison K Heather
https://pubmed.ncbi.nlm.nih.gov/30051938Actively Recruiting
Led by Wingate Institute · Updated on 2024-04-22
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
W
Wingate Institute
Lead Sponsor
W
Weizmann Institute of Science
Collaborating Sponsor
Researchers are studying the effects of training load and menstrual cycle phases on performance, health, and biological markers in elite and non-elite female athletes. This observational study aims to understand how hormone changes during the menstrual cycle influence physiological parameters, injury rates, and sport emotions. The goal is to identify periods of high training load and prevent over-training by tracking various health and performance indicators over one year. The study involves 200 premenopausal female athletes who will be followed for 12 months. Participants will be tested at three time points reflecting different training load phases: low, moderate, and high. Tests include blood sampling during menstrual cycle phases, stool sample collection for microbiome analysis, performance tests like VO2max and strength measurements, and questionnaires about health, nutrition, and psychological state. Both elite and non-elite athletes will be included, with schedules adjusted to their training plans and menstrual status. Participants will attend sessions to complete physical tests, provide biological samples, and fill out questionnaires multiple times during the study year. Blood tests will be drawn fasting and in the morning, timed with menstrual cycle phases when possible. Training load will be monitored using diaries, devices like Garmin watches, and subjective ratings. Injury data will be recorded by medical professionals. Researchers will analyze stool microbiome, serum metabolites, physical performance, body composition, and psychological measures. This comprehensive monitoring aims to clarify how menstrual cycle phases and training load affect female athletes over time.
CONDITIONS
Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility assessment at the Wingate institute
Duration - 12 months
Participants track menstrual cycles using a smartphone app and record daily wellness status, training load, and food intake diaries throughout the 12-month study period.
Daily tracking with smartphone apps and diaries; no in-person visits for this stage
Duration - 3 assessment periods over 12 months
Participants undergo testing at three distinct time points reflecting different training loads (low, moderate, high) over the year, including questionnaires, blood tests, stool sample collection, and performance tests.
3 visits (in-person) for testing aligned with training phases; blood tests scheduled during specific menstrual phases for those with regular cycles
Total: 1 location
1
Wingate Institute
Netanya, Israel
Actively Recruiting
Y
Yotam Shribman, B.Sc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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