NCT06377306 Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes
| NCT ID | NCT06377306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wingate Institute |
| Condition | Menstrual Cycle |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-05 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-11-05 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. 200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment.
Eligibility Criteria
Inclusion Criteria: * Elite athletes are defined as participating and competing at national and/or international level at their sports. * Non-elite athletes are defined as performing at least 3 hours of physical activity per week. Exclusion Criteria: * Currently pregnant or lactating or planning a pregnancy in the following year. * Regular drug use which may affect performance, including but not limited to performance enhancing drugs. * Any medical diagnosis, including recent or current injury, which could affect performance and/or health under the discretion of the study team.
Contact & Investigator
Rotem Kislev-Cohen, Ph.D
PRINCIPAL INVESTIGATOR
Wingate Institute
Frequently Asked Questions
Who can join the NCT06377306 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Menstrual Cycle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06377306 currently recruiting?
Yes, NCT06377306 is actively recruiting participants. Contact the research team at research@wingate.org.il for enrollment information.
Where is the NCT06377306 trial being conducted?
This trial is being conducted at Netanya, Israel.
Who is sponsoring the NCT06377306 clinical trial?
NCT06377306 is sponsored by Wingate Institute. The principal investigator is Rotem Kislev-Cohen, Ph.D at Wingate Institute. The trial plans to enroll 200 participants.