Low Energy Availability, Menstrual Irregularity, and Low Bone Mass

June 22, 2011 updated by: USDA, Western Human Nutrition Research Center

The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this project is to examine the relationships among low energy availability, H-P-A axis, menstrual function and bone density and bone turnover in high school female cross country runners. Our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Marta Van Loan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adolescent female cross country runners

Description

Inclusion Criteria:

  • high school female cross country runners
  • ages 15-17 years
  • 1-5 years experience as cross country runner
  • 25 miles or more/week training

Exclusion Criteria:

  • medications known to affect bone metabolism
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
adolescent female endurance athletes
High school female cross country runners in San Diego.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Energy availability
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

San Diego State University

Investigators

  • Study Chair: Marta D Van Loan, Ph.D., USDA, ARS, Western Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200816305-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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