Low Energy Availability, Menstrual Irregularity, and Low Bone Mass

Bone Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059968
• Other study ID #: 200816305-1
• 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

• Bone Density
• Energy Availability

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