Clinical Trials Logo

Clinical Trial Summary

The investigators propose a prospective, longitudinal, department funded study protocol to evaluate whether changes in energy availability, during a period of highly intensified exercise training, will increase bone turnover markers and decrease ovarian function and exercise performance, in a dose-dependent fashion in competitive female athletes.


Clinical Trial Description

Female athletes participating in sports which emphasize leanness as a factor to success, while also imposing large exercise training loads, present a high prevalence of endocrine and metabolic alterations linked to low energy stores, including suppressed ovarian function and bone loss. Increased bone turnover resulting from low energy stores and suppressed estrogen production may hold the most adverse consequences for long term health, increasing the risk of premature osteopenia, while increasing the risk of stress fractures in the short term. Chronically low energy stores may also contribute to the development of overreaching and overtraining syndromes, characterized by excessive, lasting fatigue and long-term decreases in performance, which can compromise these athletes' health and athletic career. The investigators propose the first longitudinal study aiming to demonstrate the link between low energy status, impaired ovarian function, bone turnover and decreased performance in free-living, competitive female athletes. After a 4-week baseline period of habitual training, athletes will undergo 4 weeks of intensified training (IT), during which the exercise load is increased by 30% from their individual baseline load in order to sharply increase energy expenditure. As athletes will be let to freely adjust their food intake, the investigators aim to test the hypothesis that athletes will fail to adjust food intake sufficiently to match energy expenditure, and that the resulting decrease in energy availability (EA, energy intake - energy expenditure from exercise) will influence, in a dose-dependent fashion, the suppression of estrogen production, the increase in bone turnover and the severity of performance decrement. The IT period will then be followed by a 2-week taper (REC), in which exercise training volume will be reduced by 50% from baseline. The investigators will assess whether EA returns to baseline values, and characterize changes in bone turnover during this recovery period. It is hypothesized that any improvements in exercise performance resulting from IT + REC will occur in athletes who were able to remain closest to a balanced energy state during IT. Concretely linking EA to both performance and bone health may incentivize female athletes to adopt more adequate feeding behaviors for their activity level. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT02224976
Study type Interventional
Source USDA, Western Human Nutrition Research Center
Contact
Status Completed
Phase N/A
Start date January 2014
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT01927432 - Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea
Completed NCT00196391 - A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea Phase 2
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Recruiting NCT00456274 - Baselines in Reproductive Disorders N/A
Terminated NCT00556400 - Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones Phase 1/Phase 2
Completed NCT00429494 - GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients Phase 2
Completed NCT04135729 - Mental Health in Fitness Instructors
Recruiting NCT06280807 - Observation of Environment and Reproductive-Endocrine Effects
Recruiting NCT03916978 - Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women Phase 2/Phase 3
Completed NCT00243607 - Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors N/A
Completed NCT00001275 - Ovarian Follicle Function in Patients With Primary Ovarian Failure N/A
Completed NCT04938622 - Bioenergetics of Exercise-Induced Menstrual Disturbances N/A
Not yet recruiting NCT02393482 - Psychological Impact of Amenorrhea in Women With Endometriosis Phase 4
Completed NCT01206153 - Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients Phase 4
Recruiting NCT04424576 - Ovarian Morphology in Girls
Active, not recruiting NCT01785719 - Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss N/A
Recruiting NCT00383656 - Pulsatile GnRH in Anovulatory Infertility Phase 2
Terminated NCT00881608 - Study to Evaluate Menses Induction in Women Administered Proellex Phase 1
Active, not recruiting NCT01103518 - Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation Phase 4
Withdrawn NCT00827151 - Bone Mass Accrual in Adolescent Athletes Phase 3