NCT01059968

Brief Summary

This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

3 months

First QC Date

December 28, 2009

Last Update Submit

June 22, 2011

Conditions

Bone DensityEnergy Availability

Keywords

bone densityenergy availabilitymenstrual statusfemaleadolescent

Outcome Measures

Primary Outcomes (1)

  • Bone density

    3 months

Secondary Outcomes (1)

  • Energy availability

    3 months

Study Arms (1)

adolescent female endurance athletes

High school female cross country runners in San Diego.

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

adolescent female cross country runners

You may qualify if:

  • high school female cross country runners
  • ages 15-17 years
  • years experience as cross country runner
  • miles or more/week training

You may not qualify if:

  • medications known to affect bone metabolism
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marta Van Loan

Davis, California, 95616, United States

Location

Related Publications (2)

  • Wood KL, Barrack MT, Gray VB, Cotter JA, Van Loan MD, Rauh MJ, McGowan R, Nichols JF. Cognitive dietary restraint score is associated with lower energy, carbohydrate, fat, and grain intake among female adolescent endurance runners. Eat Behav. 2021 Jan;40:101460. doi: 10.1016/j.eatbeh.2020.101460. Epub 2020 Nov 25.

    PMID: 33307469DERIVED

  • Barrack MT, Van Loan MD, Rauh MJ, Nichols JF. Physiologic and behavioral indicators of energy deficiency in female adolescent runners with elevated bone turnover. Am J Clin Nutr. 2010 Sep;92(3):652-9. doi: 10.3945/ajcn.2009.28926. Epub 2010 Jul 7.

    PMID: 20610635DERIVED

Study Officials

  • Marta D Van Loan, Ph.D.

    USDA, ARS, Western Human Nutrition Research Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

December 28, 2009

First Posted

February 1, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)