NCT02224976

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

August 21, 2014

Last Update Submit

January 26, 2016

Conditions

Amenorrhea

Keywords

exercise training

Outcome Measures

Primary Outcomes (1)

  • Change in energy availability (energy intake - energy expenditure of physical activity)

    The investigators aim to capture the spectrum and variability of energy availability in endurance athletes under normal training conditions, describing in detail training regimen, total energy expenditure and nutrition habits during three distinct phases of training that are habitually followed by endurance athletes.

    Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)

Secondary Outcomes (3)

  • Change in athletic performance

    Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)

  • Change in ovarian function

    Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)

  • Change in bone turnover markers

    Baseline (week 4), after 4 weeks of intensified training (week 8) and after a two-week recovery period (week 10)

Study Arms (1)

Intensified training

EXPERIMENTAL

Volunteers will increase exercise training by 30% from baseline

Behavioral: Intensified Training

Interventions

Intensified TrainingBEHAVIORAL

Volunteers will increase exercise training by 30% from baseline

Intensified training

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (1)

  • 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.

    PMID: 33651630DERIVED

Related Links

MeSH Terms

Conditions

Amenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gretchen A Casazza, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 25, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 28, 2016

Record last verified: 2015-09

Locations

US(1)