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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01059968
Other study ID # 200816305-1
Secondary ID
Status Completed
Phase N/A
First received December 28, 2009
Last updated June 22, 2011
Start date September 2008
Est. completion date December 2009

Study information

Verified date June 2011
Source USDA, Western Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 17 Years
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Marta Van Loan Davis California

Sponsors (2)

Lead Sponsor Collaborator
USDA, Western Human Nutrition Research Center San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone density 3 months No
Secondary Energy availability 3 months No
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