Effect of Intense Training on Ovarian Function and Bone Turnover

NCT ID: NCT02224976

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensified training

Volunteers will increase exercise training by 30% from baseline

Group Type EXPERIMENTAL

Intensified Training

Intervention Type BEHAVIORAL

Volunteers will increase exercise training by 30% from baseline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensified Training

Volunteers will increase exercise training by 30% from baseline

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* competitive endurance runners (racing in events ranging from 10km to ultra-marathons)
* training at least 5 days per week over the past 12 months, and more than 30 miles per week
* regular menstrual cycles (24-35 days) over the past 6 months
* maximal oxygen consumption (VO2max) \> 50ml/kg/min
* English speaking

Exclusion Criteria

* smoker
* amenorrhea
* pregnant or lactating in the past 2 years
* chronic disease that will affect bone health, metabolism or the cardiorespiratory system
* take medications that have cardiovascular or metabolic effects
* present any contra-indication to exercise testing (cardiovascular abnormalities)
* report any major illness or injury preventing training for more than 4 weeks over the past 3 months
* a history of clinical anorexia nervosa or bulimia nervosa
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gretchen A Casazza, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Schaal K, VanLoan MD, Hausswirth C, Casazza GA. Decreased energy availability during training overload is associated with non-functional overreaching and suppressed ovarian function in female runners. Appl Physiol Nutr Metab. 2021 Oct;46(10):1179-1188. doi: 10.1139/apnm-2020-0880. Epub 2021 Mar 2.

Reference Type DERIVED
PMID: 33651630 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ars.usda.gov/Main/docs.htm?docid=11240

USDA Western Human Nutrition Research Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FL94

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.