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Low Energy Availability, Menstrual Irregularity, and Low Bone Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059968
First Posted: February 1, 2010
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
San Diego State University
Information provided by:
USDA, Western Human Nutrition Research Center
  Purpose
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.

Condition
Bone Density Energy Availability

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Bone density [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Energy availability [ Time Frame: 3 months ]

Enrollment: 45
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
adolescent female endurance athletes
High school female cross country runners in San Diego.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
adolescent female cross country runners
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059968


Locations
United States, California
Marta Van Loan
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
San Diego State University
Investigators
Study Chair: Marta D Van Loan, Ph.D. USDA, ARS, Western Human Nutrition Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marta Van Loan, USDA, ARS, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01059968     History of Changes
Other Study ID Numbers: 200816305-1
First Submitted: December 28, 2009
First Posted: February 1, 2010
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by USDA, Western Human Nutrition Research Center:
bone density
energy availability
menstrual status
female
adolescent