Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity

Not Applicable

Completed

• Conditions: Menstrual Irregularity
• Interventions: Behavioral: EAMD+Calories

• Registration Number: NCT00392873
• Lead Sponsor: Penn State University

Brief Summary

The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.

Detailed Description

Low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer from reductions in bone mineral density, particularly in the lumbar spine. Bone loss observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also associated with a high prevalence of stress fractures. Increased calorie intake should help improve energy status, menstrual status, and bone health.

Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned to either receive additional calories or serve as controls. A group of premenopausal women with normal menstrual periods will also be used for comparison.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 233

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EAMD+Calories	EAMD+Calories	This group contains women with exercise-associated menstrual disturbances (EAMD) and receives an intervention of increased caloric intake during the 12-month intervention. The targeted increase in caloric intake is 20-30% of baseline energy expenditure.

Primary Outcome Measures

Name	Time	Method
Bone mineral density	1 year
Reproductive hormones	1 year
Metabolic bone markers	1 year
Metabolic hormones	1 year

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Inventory-2 (EDI-2)	1 year
Three Factor Eating Questionnaire	1 year

Trial Locations

Locations (1)

Women's Health and Exercise Laboratories, The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States